Initiative for Quality improvement and Epidemiology in Multidisciplinary Diabetic Foot Clinics (IQEDFoot)

Version: from 01/01/2024 - 31/07/2025
Status: active
Unique ID: patient ID and audit period
How to create a CSV file for this data collection?

Start date: 10/01/2024

Full view CSV column names Validation rules Reference lists Computed expressions Additional information CSV extract

date

Start date audit period

Not to be included in the CSV.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

start_date_audit_period

Default value:

2024-01-01

Required:

true

Read only

Validation

The date of the first contact cannot fall before the start date of the audit period (error)
The date of birth cannot fall after the start date of the audit period (error)
Age is below 18 years. Please check the date of birth. (warning)
Age is above 100 years. Please check the date of birth. (warning)

date

End date inclusion period

Not to be included in the CSV.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

end_date_inclusion_period

Default value:

2024-12-31

Required:

true

Read only

Validation

The date of the first contact cannot fall after the end date of the inclusion period (error)

date

End date audit period

Not to be included in the CSV.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

end_date_audit_period

Default value:

2025-07-31

Required:

true

Read only

Validation

The date of the last contact cannot fall after the end date of the audit period (error)

1 General patient characteristics at inclusion

list

Treating physician

This is a container for multiple answers. See the reference documentation for more details. Below you can find the information about the fields of the container

List items

text

NIHDI-code of the treating physician

Technical specs

CSV column name:

treating_physician|nihdicode_of_the_treating_physician

Length:

100

Reference list:

PHYSICIAN

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.HealthProfessional

Data element:

HealthProfessionalIdentificationNumber

patient identificator

National registry ID of the patient

Help

Please encode a social security identification number (SSIN). Please note that the patient ID is always pseudonymised before being transferred to Healthdata.

Technical specs

CSV column name:

patient_id

Required:

true

Stable:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

PatientIdentificationNumber

Validation

The validity of the national register number is checked with the mod97 check.

Fields

Section help

Please encode a social security identification number (SSIN). Please note that the patient ID is always pseudonymised before being transferred to Healthdata.

text

Internal patient ID

Help

This field can be used to enter an internal ID or reference number. It is available for internal use only and is not transferred to the Healthdata. If there is an integration between HD4DP and your organisation's patient administration system, additional patient identification information such as date of birth, sex and SSIN can be automatically enriched based on this internal patient ID. Please do not encode the social security identification number (SSIN) in this field. The SSIN must be encoded in the patient ID field.

Technical specs

CSV column name:

patient_id|internal_patient_id

Required:

false

Stable:

true

boolean

Generated

Help

The patient_id|generated column can be set to 'TRUE' for an automatically generated patient_id.This column should only be added in case the patient_id is empty. If the column is set to 'TRUE', a patient_id is automatically generated based on the name, first name, date of birth and sex of the patient.

Technical specs

CSV column name:

patient_id|generated

Required:

false

Options

Label	Value
Yes	TRUE
No	FALSE

text

Name

Help

The name of the patient is never transferred to Healthdata and is available for your information only.

Technical specs

CSV column name:

patient_id|name

Length:

Required:

true

Stable:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

LastName

text

First name

Help

The first name of the patient is never transferred and is available for your information only.

Technical specs

CSV column name:

patient_id|first_name

Length:

Required:

true

Stable:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

FirstNames

date

Date of birth

Help

If only the year is known, then enter 01/07/yyyy (e.g. 01/07/1989). If only the year and month are known, then enter 15/mm/yyyy (e.g. 15/06/2001).

Technical specs

Format:

DD/MM/YYYY

CSV column name:

patient_id|date_of_birth

Required:

true

Stable:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DateOfBirth

Validation

The date of diagnosis of diabetes cannot fall before the date of birth (error)
The date of birth cannot fall after the start date of the audit period (error)
Age is below 18 years. Please check the date of birth. (warning)
Age is above 100 years. Please check the date of birth. (warning)
You have indicated that the patient was born on January 1st. Was the patient really born on January 1st, or did you choose this date because you do not know the exact date? If the latter is the case, please indicate July 1st (01/07/yyyy) as date of birth. Note that the date of birth can easily be deduced from the national registry number. (warning)
The date of diagnosis of diabetes falls on the date of birth. Please check your answers. (warning)
The approximate date on which the index foot problem started cannot fall before the date of birth (error)

choice

Sex

Technical specs

CSV column name:

patient_id|sex

Required:

true

Stable:

true

Options

Label	Value
Female	F
Male	M
Unknown	U

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

Gender

Validation

You indicated that the patient's sex is "unknown". Please check if this answer is correct. (warning)

text

Place of residence

Help

For patients not living in Belgium, choose postal code "9999" and provide the country of residence in the follow-up question.

Technical specs

CSV column name:

patient_id|place_of_residence

Length:

Reference list:

POSTAL_CODE

Required:

false

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

Place of residence

Validation

You have indicated that the patient does not live in Belgium, but you did not provide the country of residence. Please try to provide this information. (warning)

boolean

Deceased?

Technical specs

CSV column name:

patient_id|deceased

Required:

false

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DeathIndicator

Validation

You have indicated that the patient died during follow-up, but you did not provide the date of death. Please try to provide this date. (warning)

Options

Label	Value
Yes	TRUE
No	FALSE

date

Date of death

Help

If only the year is known, then enter 01/07/yyyy (e.g. 01/07/1989). If only the year and month are known, then enter 15/mm/yyyy (e.g. 15/06/2001).

Technical specs

Format:

DD/MM/YYYY

CSV column name:

patient_id|date_of_death

Only when:

Required:

false

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

DateOfDeath

Validation

The date of healing cannot fall after the date of death (error)
The date of major amputation cannot fall after the date of death (error)
You have indicated that the patient died during follow-up, but you did not provide the date of death. Please try to provide this date. (warning)
The date of death cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of death cannot be greater than 215 days (7 months) (error)
The date of death cannot fall on the date of the first contact (error)

text

Country of residence

Technical specs

CSV column name:

country_of_residence

Length:

100

Reference list:

COUNTRY

Only when:

Required:

false

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Patient

Data element:

Country

Validation

If the country of residence is Belgium, then please indicate a postal code that is not 9999. (warning)
You have indicated that the patient does not live in Belgium, but you did not provide the country of residence. Please try to provide this information. (warning)

2 When and how did the patient first present to a member of your diabetic foot clinic?

date

Date of the FIRST contact with a member of your diabetic foot clinic for the index foot problem

Help

The first contact can be in the emergency department, during out-patient consultations or in one of your hospital’s wards (for in-patients). The date of the first contact is the date of inclusion for follow-up in IQED-Foot.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_the_first_contact_with_a_member_of_your_diabetic_foot_clinic_for_the_index_foot_problem

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Encounter

Data element:

StartDateTime

Validation

The date of the last contact cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the last contact cannot be greater than 215 days (7 months) (error)
The date of the first contact cannot fall before the start date of the audit period (error)
The date of the first contact cannot fall after the end date of the inclusion period (error)
The date of major amputation cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of major amputation cannot be greater than 215 days (7 months) (error)
The date of healing cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of healing cannot be greater than 215 days (7 months) (error)
The date of death cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of death cannot be greater than 215 days (7 months) (error)
The date of death cannot fall on the date of the first contact (error)
The date of healing falls on the date of the first contact. This is not allowed. If the lesion was healed at the time of inclusion, then it should not be included for registration in IQED-Foot. (error)
The approximate date on which the index foot problem started cannot fall after the date of the first contact (error)
The index foot problem started more than 1 year before the first contact. Please check your answers. (warning)

date

Approximate date on which the index foot problem started

Help

If the exact date is unknown and the patient only reported the month and the year in which the index foot problem started, then enter 15/mm/yyyy (e.g. 15/09/2017). If the patient only reported the year, then enter 01/07/yyyy (e.g. 01/07/2014). If the index foot problem was discovered during the first contact with a member of your diabetic foot clinic, then enter the date of the first contact.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

approximate_date_on_which_the_index_foot_problem_started

Required:

false

Validation

The approximate date on which the index foot problem started cannot fall before the date of birth (error)
The approximate date on which the index foot problem started cannot fall after the date of the first contact (error)
The index foot problem started more than 1 year before the first contact. Please check your answers. (warning)

choice

The patient was referred to you by a healthcare professional

Help

Referral by a healthcare professional (HCP) to the emergency department or out-patient consultation of your diabetic foot clinic. If the patient presented on his/her own initiative, then select "no". If the foot problem was discovered during a planned follow-up visit, then select "no". If the patient was already hospitalized at the time of the first contact with a member of the diabetic foot clinic, try to ascertain whether the hospitalization was preceded by referral by an HCP or whether the patient came on his/own initiative.

Technical specs

CSV column name:

the_patient_was_referred_to_you_by_a_healthcare_professional

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

choice

Does the patient present him/herself in your diabetic foot clinic for a second opinion?

Technical specs

CSV column name:

CD_SECON_OPI

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

Where is the patient further followed up and treated for the current foot problem?

Technical specs

CSV column name:

CD_FLLWUP_CURR_FT_PROB

Only when:

Required:

false

Options

Label	Value
In your diabetic foot clinic	1
In the diabetic foot clinic of initial opinion	2
In both diabetic foot clinics	3

3 Patient and foot characteristics at inclusion

3.1 Medical history

choice

Diabetes type

Technical specs

CSV column name:

diabetestype

Required:

true

Stable:

true

Options

Label	Value
1	1
2	2
Other type	3
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

Diabetes type cannot have "No response" as response (error)

date

Date of diagnosis of diabetes

Help

If only the year is known, then enter 01/07/yyyy (e.g. 01/07/1989). If only the year and month are known, then enter 15/mm/yyyy (e.g. 15/06/2001).

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_diagnosis_of_diabetes

Required:

false

Stable:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatusDate

Validation

The date of diagnosis of diabetes cannot fall before the date of birth (error)
The date of diagnosis of diabetes cannot fall after the date of the last contact (error)
You have indicated that the diagnosis of diabetes was made on January 1st. Is the date of diagnosis really January 1st, or did you choose this date because you do not know the exact date? If the latter is the case, please indicate July 1st (01/07/yyyy) as date of diagnosis of diabetes. (warning)
The date of diagnosis of diabetes falls on the date of birth. Please check your answers. (warning)

choice

Smoking status

Help

Ex-smoker: the patient has not smoked for > 6 months

Technical specs

CSV column name:

smoking_status

Default value:

Required:

false

Options

Label	Value
Never smoked	0
Ex-smoker	1
Smoker	2
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.TobaccoUse

Data element:

TobaccoUseStatus

choice

Does the patient suffer from renal insufficiency?

Help

Renal insufficiency = MDRD eGFR < 60 mL/min/1.73 m² (= Chronic kidney disease (CKD) stage 3-5).

Technical specs

CSV column name:

does_the_patient_suffer_from_renal_insufficiency

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Has the patient already received a kidney transplant or is he receiving hemodialysis or peritoneal dialysis?

Technical specs

CSV column name:

has_the_patient_already_received_a_kidney_transplant_or_is_he_receiving_hemodialysis_or_peritoneal_dialysis

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Has the patient ever undergone a percutaneous coronary intervention (PCI)?

Technical specs

CSV column name:

has_the_patient_ever_undergone_a_percutaneous_coronary_intervention_pci

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Has the patient ever received coronary bypass surgery?

Technical specs

CSV column name:

has_the_patient_ever_received_coronary_bypass_surgery

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Has the patient ever suffered a myocardial infarction?

Technical specs

CSV column name:

has_the_patient_ever_suffered_a_myocardial_infarction

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Has the patient ever suffered a transient ischemic attack?

Technical specs

CSV column name:

has_the_patient_ever_suffered_a_transient_ischemic_attack

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Has the patient ever suffered a stroke?

Technical specs

CSV column name:

has_the_patient_ever_suffered_a_stroke

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Has the patient ever received revascularization of the lower limbs?

Help

Counting both endovascular and surgical revascularizations.

Technical specs

CSV column name:

has_the_patient_ever_received_revascularization_of_the_lower_limbs

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Is the patient unable to stand or walk without help?

Help

If the patient is unable to stand or walk without help, please select Yes.

Technical specs

CSV column name:

is_the_patient_unable_to_stand_or_walk_without_help

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Mobility

Data element:

HoudingVeranderen

choice

The nutritional status of the patient has been evaluated

Help

An evaluation of the nutritional status performed in the 6 months BEFORE inclusion in IQED-Foot is also eligible.

Technical specs

CSV column name:

CD_NUTR_STA_PAT_EVAL

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

3.2 Anthropometry

number

Weight (kg)

Technical specs

CSV column name:

weight_kg

Length:

Required:

false

Validation

Weight is smaller than 30 kg (warning)
Weight (kg) must be an integer (error)
Weight cannot be smaller than 0 kg (error)
Weight is larger than 250 kg (warning)

number

Height (cm)

Technical specs

CSV column name:

height_cm

Length:

Required:

false

Validation

Length is smaller than 100 cm (warning)
Height (cm) must be an integer (error)
Length cannot be smaller than 0 cm (error)
Length is larger than 230 cm (warning)

3.3 Inventory of past and current foot problems and nomination of index foot problem

Section help

DEFINITIONS used throughout this section - PLEASE READ VERY CAREFULLY:
"Diabetic foot lesion": ulcer or necrosis/gangrene located on the foot or the malleoli and resulting from diabetic neuropathy and/or peripheral arterial disease.
"Active Charcot foot": determined by temperature difference (>= 2°C compared to the contralateral foot), imaging, or inflammation of the foot (redness, warmth, oedema) for which no other cause can be found. An active Charcot foot may present with or without deformity or morphological abnormalities. Osteomyelitis may be present, but should have been excluded as the primary cause of inflammation. Registration of a reactivated Charcot foot in this category is allowed.
"Inactive Charcot foot": a foot with remaining deformity due to a previous active Charcot foot, but without evidence of current inflammation.
"Minor amputation": an amputation below the ankle, i.e. after which heel support is still possible. Classify ankle disarticulation (Syme’s amputation) as a minor amputation.
"Major amputation": an amputation above the ankle, i.e. after which heel support is no longer possible.

3.3.1 Which PAST foot problem(s), if any, was/were identified during the history taking at the time of the first contact with a member of the diabetic foot clinic?

Section help

For each foot, check all past foot problems that apply. READ NOTE ABOVE FOR DEFINITIONS!

multichoice

PAST problems on LEFT foot

Technical specs

CSV column name:

past_problems_on_left_foot

Required:

false

Options

Label	Value
History of one or more diabetic foot lesions	history_of_one_or_more_diabetic_foot_lesions_left
History of Charcot foot	history_of_charcot_foot_left
History of minor amputation	history_of_minor_amputation_left
History of major amputation	history_of_major_amputation_left

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

A patient with a bilateral major amputation no longer has feet and therefore cannot be included for IQED-Foot. (error)
An inactive Charcot foot has been selected for CURRENT problems on the LEFT foot . Please select for PAST problems on the LEFT foot a history of Charcot foot (error)

multichoice

PAST problems on RIGHT foot

Technical specs

CSV column name:

past_problems_on_right_foot

Required:

false

Options

Label	Value
History of one or more diabetic foot lesions	history_of_one_or_more_diabetic_foot_lesions_right
History of Charcot foot	history_of_charcot_foot_right
History of minor amputation	history_of_minor_amputation_right
History of major amputation	history_of_major_amputation_right

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

A patient with a bilateral major amputation no longer has feet and therefore cannot be included for IQED-Foot. (error)
An inactive Charcot foot has been selected for CURRENT problems on the RIGHT foot . Please select for PAST problems on the RIGHT foot a history of Charcot foot (error)

3.3.2 Which CURRENT foot problem(s) was/were identified at the time of the first contact with a member of the diabetic foot clinic?

Section help

For each foot, check all current foot problems that apply. READ NOTE ABOVE FOR DEFINITIONS! Complete the section on current foot problems after initial bedside and/or surgical debridement (multiple ulcers may have become a single large ulcer).

multichoice

CURRENT problems on LEFT foot

Technical specs

CSV column name:

current_problems_on_left_foot

Only when:

Required:

false

Options

Label	Value
One diabetic foot lesion of Wagner grade 1 or higher	one_diabetic_foot_lesion_of_wagner_grade_1_or_higher_left
More than one diabetic foot lesion of Wagner grade 1 or higher	more_than_one_diabetic_foot_lesion_of_wagner_grade_1_or_higher_left
Active Charcot foot	active_charcot_foot_left
Inactive Charcot foot	inactive_charcot_foot_left

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

If there is more than one diabetic foot lesion on the left foot, please uncheck the first option (error)
The foot on which the index foot problem is situated does not satisfy the following criterion: a current diabetic foot lesion and/or a current active Charcot foot. If the other foot satisfies this criterion, then change the answer to the question The index foot problem is situated on which foot?. If the other foot also does not satisfy this criterion, then the patient is not eligible for inclusion in IQED-Foot and another patient needs to be registered. (error)
You have checked both "active" and "inactive Charcot foot" as current problems on the left foot. Please choose only one. If there are signs of inflammation, then the Charcot foot is active. In case of a reactivated Charcot foot choose "Active Charcot foot" as current foot problem and choose "History of Charcot foot" as past foot problem. (error)
The index diabetic foot lesion has to be of Wagner grade 2 or higher. Only if the index foot problem also consists of an active Charcot foot, is it acceptable to register a Wagner grade 1 diabetic foot lesion as index diabetic foot lesion. (error)
An inactive Charcot foot has been selected for CURRENT problems on the LEFT foot . Please select for PAST problems on the LEFT foot a history of Charcot foot (error)

multichoice

CURRENT problems on RIGHT foot

Technical specs

CSV column name:

current_problems_on_right_foot

Only when:

Required:

false

Options

Label	Value
One diabetic foot lesion of Wagner grade 1 or higher	one_diabetic_foot_lesion_of_wagner_grade_1_or_higher_right
More than one diabetic foot lesion of Wagner grade 1 or higher	more_than_one_diabetic_foot_lesion_of_wagner_grade_1_or_higher_right
Active Charcot foot	active_charcot_foot_right
Inactive Charcot foot	inactive_charcot_foot_right

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

If there is more than one diabetic foot lesion on the right foot, please uncheck the first option. (error)
The foot on which the index foot problem is situated does not satisfy the following criterion: a current diabetic foot lesion and/or a current active Charcot foot. If the other foot satisfies this criterion, then change the answer to the question The index foot problem is situated on which foot?. If the other foot also does not satisfy this criterion, then the patient is not eligible for inclusion in IQED-Foot and another patient needs to be registered. (error)
You have checked both "active" and "inactive Charcot foot" as current problems on the right foot. Please choose only one. If there are signs of inflammation, then the Charcot foot is active. In case of a reactivated Charcot foot choose "Active Charcot foot" as current foot problem and choose "History of Charcot foot" as past foot problem. (error)
The index diabetic foot lesion has to be of Wagner grade 2 or higher. Only if the index foot problem also consists of an active Charcot foot, is it acceptable to register a Wagner grade 1 diabetic foot lesion as index diabetic foot lesion. (error)
An inactive Charcot foot has been selected for CURRENT problems on the RIGHT foot . Please select for PAST problems on the RIGHT foot a history of Charcot foot (error)

choice

The index foot problem is situated on which foot?

Help

The index foot problem is the problem with the poorest prognosis.
Eligible index foot problems consist of:
a diabetic foot lesion of Wagner grade 2 or higher (with or without an inactive Charcot foot)
OR
an active Charcot foot (with or without a diabetic foot lesion of Wagner grade 1 or higher)

Technical specs

CSV column name:

the_index_foot_problem_is_situated_on_which_foot

Default value:

no_response

Required:

false

Options

Label	Value
Left foot	left_foot
Right foot	right_foot
No response	no_response

Validation

The foot on which the index foot problem is situated does not satisfy the following criterion: a current diabetic foot lesion and/or a current active Charcot foot. If the other foot satisfies this criterion, then change the answer to the question The index foot problem is situated on which foot?. If the other foot also does not satisfy this criterion, then the patient is not eligible for inclusion in IQED-Foot and another patient needs to be registered. (error)
The index diabetic foot lesion has to be of Wagner grade 2 or higher. Only if the index foot problem also consists of an active Charcot foot, is it acceptable to register a Wagner grade 1 diabetic foot lesion as index diabetic foot lesion. (error)
"The index foot problem is situated on which foot?" cannot have "No response" as response (error)

3.4 Description of the index diabetic foot lesion

Section help

If the index foot problem consists of more than one diabetic foot lesion, please choose the lesion with the poorest prognosis and complete the questions below for this index diabetic foot lesion. Note that the index diabetic foot lesion has to be of Wagner grade 2 or higher, except if it occurs on an active Charcot foot.

choice

Indicate the WAGNER grade of the index diabetic foot lesion

Help

(Grade 0 = No ulcer, but a high-risk foot)
Grade 1 = Superficial ulcer
Grade 2 = Deep ulcer with the following characteristics: involvement of ligaments, tendons, joint capsules, or fascia; no abscess or osteomyelitis
Grade 3 = Deep ulcer with abscess or osteomyelitis
Grade 4 = Gangrene of a portion of the forefoot (e.g. toes)
Grade 5 = Extensive gangrene of the foot

Technical specs

CSV column name:

indicate_the_wagner_grade_of_the_index_diabetic_foot_lesion

Default value:

Only when:

Required:

false

Options

Label	Value
1	1
2	2
3	3
4	4
5	5
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

Wagner grade cannot have "No response" as response (error)
The index diabetic foot lesion has to be of Wagner grade 2 or higher. Only if the index foot problem also consists of an active Charcot foot, is it acceptable to register a Wagner grade 1 diabetic foot lesion as index diabetic foot lesion. (error)
You have indicated that the index lesion is of Wagner grade 5 (gangrene of the entire foot), but you did not indicate that the patient received a major amputation. Because this is unlikely, please check your answers. (warning)

choice

Indicate the PEDIS PERFUSION grade of the index diabetic foot lesion

Help

Grade 1 = palpable pulses and/or ABI (ankle-brachial index) 0.9-1.1 and/or TBI (toe-brachial index) > 0.6 and/or TcpO2 (transcutaneous oxygen pressure) > 60 mmHg
Grade 2 = no palpable pulses and/or ABI < 0.9 but AP (ankle pressure) >= 50 mmHg and/or TBI <= 0.6 but TP (toe pressure) >= 30 mmHg and/or TcpO2 30-60 mmHg
Grade 3 = no palpable pulses and clinical signs of severe ischemia and/or AP < 50 mmHg and/or TP < 30 mmHg and/or TcpO2 < 30 mmHg

Technical specs

CSV column name:

perfusion

Default value:

Only when:

Required:

false

Options

Label	Value
Grade 1 - No peripheral vascular abnormalities	1
Grade 2 - Subcritical ischemia	2
Grade 3 - Critical ischemia	3
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Indicate the PEDIS EXTENT grade of the index diabetic foot lesion

Help

The index diabetic foot lesion should be graded after initial bedside and/or surgical debridement, to the extent that debridement is necessary to be able to grade the lesion.

Technical specs

CSV column name:

extent_in_cm

Default value:

Only when:

Required:

false

Options

Label	Value
	1
>= 1 cm² and	2
>= 3 cm²	3
No response	9

choice

Indicate the PEDIS DEPTH grade of the index diabetic foot lesion

Help

The index diabetic foot lesion should be graded after initial bedside and/or surgical debridement, to the extent that debridement is necessary to be able to grade the lesion.

Technical specs

CSV column name:

depth_scored_after_debridement

Default value:

Only when:

Required:

false

Options

Label	Value
Grade 1 - Superficial	1
Grade 2 - Deep (fascia, muscle or tendon)	2
Grade 3 - Probing to bone	3
No response	9

choice

Indicate the PEDIS INFECTION grade of the diabetic foot lesion

Help

The index diabetic foot lesion should be graded after initial bedside and/or surgical debridement, to the extent that debridement is necessary to be able to grade the lesion.
Grade 1 = no infection
Grade 2 = erythema < 2 cm
Grade 3 = erythema > 2 cm or abscess/osteomyelitis/arthritis/fasciitis
Grade 4 = toxic shock; T°; leukocytosis (> 12000 or < 4000/mm³); 10% immature (band) forms

Technical specs

CSV column name:

infection_scored_after_debridement

Default value:

Only when:

Required:

false

Options

Label	Value
Grade 1 - No infection	1
Grade 2 - Superficial infection	2
Grade 3 - Deep infection	3
Grade 4 - Systemic infection	4
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

Indicate the PEDIS SENSATION grade of the index diabetic foot lesion

Help

Grade 1 = normal sensation
Grade 2 = monofilament negative on 2 out of 3 sites and/or 128 Hz tuning fork negative and/or vibration threshold > 25 V

Technical specs

CSV column name:

sensation

Default value:

Only when:

Required:

false

Options

Label	Value
No loss of protective sensation	1
Loss of protective sensation	2
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

static image

Diabetic foot lesion location chart

Technical specs

CSV column name:

diabetic_foot_lesion

Only when:

Required:

false

multichoice

Indicate the LOCATION of the index diabetic foot lesion

Help

Refer to the regions shown in the figure above. Then, below, please check the region(s) in which the index diabetic foot lesion is located. The index diabetic foot lesion may span multiple ADJACENT regions. A lateral or medial lesion of the fore- or midfoot should be recorded as a plantar lesion.

Technical specs

CSV column name:

indicate_the_location_of_the_index_diabetic_foot_lesion

Only when:

Required:

false

Options

Label	Value
TOES (red): plantar, dorsal, lateral and medial aspects, including tip of the toe	toes
PLANTAR FOREFOOT (orange): plantar, lateral and medial aspects of the metatarsal heads	plantar_forefoot
PLANTAR MIDFOOT (yellow): plantar, lateral and medial aspects of the midfoot	plantar_midfoot
DORSUM (blue): the dorsal aspect of the forefoot (excl. toes) and midfoot, anterior and distal to the malleoli	dorsum
HEEL (green): the plantar, lateral and medial aspects of the calcaneal tuberosity and the zone posterior and distal to the malleoli	heel
MALLEOLUS (purple)	malleolus

Validation

The index foot lesion is located in two or more non-adjacent regions, suggesting that the index foot lesion is in fact composed of multiple separate lesions, which is not permissible. (warning)

3.5 Description of the index active Charcot foot

static image

Charcot joints location chart

Technical specs

CSV column name:

active_charcot_foot

Only when:

Required:

false

multichoice

Indicate the LOCATION of the joints involved in the active Charcot foot

Help

Refer to the figure above showing the classification system of Charcot joints by Sanders and Frykberg. Then, below, please check all joints that are involved in the active Charcot foot.

Technical specs

CSV column name:

indicate_the_location_of_the_joints_involved_in_the_active_charcot_foot

Only when:

Required:

false

Options

Label	Value
Type 1: interphalangeal joints and phalanges, or metatarsophalangeal joints and metatarsals	type_1_interphalangeal_joints_and_phalanges_or_metatarsophalangeal_joints_and_metatarsals
Type 2: tarsometatarsal joints	type_2_tarsometatarsal_joints
Type 3: naviculocuneiform joints, or talonavicular and calcaneocuboid joints	type_3_naviculocuneiform_joints_or_talonavicular_and_calcaneocuboid_joints
Type 4: ankle joint	type_4_ankle_joint
Type 5: calcaneus	type_5_calcaneus

choice

There was foot deformity at the time of inclusion

Technical specs

CSV column name:

there_was_foot_deformity_at_the_time_of_inclusion

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Validation

You have indicated that the index lesion was located on a Charcot pressure point, but you have also indicated that there was no foot deformity at inclusion. A foot without deformity is unlikely to have pressure points. Please check your answers. (warning)

choice

The index diabetic foot lesion was located on a Charcot pressure point

Technical specs

CSV column name:

the_index_diabetic_foot_lesion_was_located_on_a_charcot_pressure_point

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Validation

You have indicated that the index lesion was located on a Charcot pressure point, but you have also indicated that there was no foot deformity at inclusion. A foot without deformity is unlikely to have pressure points. Please check your answers. (warning)

4 Treatment of the index foot problem during follow-up

4.1 Wound care

choice

Out-patient sharp debridement was performed

Help

"Out-patient" means sharp debridement performed outside the operating room.

Technical specs

CSV column name:

outpatient_sharp_debridement_was_performed

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Nested option fields

When 1 Is selected:
multichoice
Out-patient sharp debridement was performed by
Help
Check all disciplines that performed out-patient sharp debridement.
Technical specs
CSV column name:
outpatient_sharp_debridement_was_performed|outpatient_sharp_debridement_was_performed_by
Required:
false
Options
Label Value
Nurse nurse
Podiatrist podiatrist
Medical doctor medical_doctor

Label	Value
Nurse	nurse
Podiatrist	podiatrist
Medical doctor	medical_doctor

choice

Is the patient suited for out-patient negative pressure therapy?

Help

"Out-patient" means negative pressure therapy performed outside the operating room.

Technical specs

CSV column name:

CD_OUTPAT_NPT

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

Out-patient negative pressure therapy was performed?

Technical specs

CSV column name:

CD_OUTPAT_NPT_PERFORM

Only when:

Required:

false

Options

Label	Value
Yes	1
No	0
No, due to the high cost for the patient	2

choice

A wound tissue sample was sent for microbiological examination

Help

A wound tissue sample can be collected by scraping with a dermal curette or scalpel from the base of a debrided ulcer, by punch biopsy or by needle aspirate of purulent secretions. An antibiotic-free interval of at least 2 days before taking the wound tissue sample is recommended by the IWGDF. A wound swab is NOT eligible.

Technical specs

CSV column name:

CD_WND_TISS_MCRBCAL_EXAM

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

A bone biopsy was sent for microbiological examination

Help

An antibiotic-free interval of at least 2 weeks before taking the bone biopsy is recommended by the IWGDF.

Technical specs

CSV column name:

CD_BONE_BIOSY_MCRBCAL_EXAM

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

4.2 Off-loading

Section help

Off-loading practices to treat the index foot lesion and/or index active Charcot foot. Off-loading of the lower leg using bed rest, crutches or a wheelchair are not considered in this section.

choice

Off-loading using a below-knee cast

Help

E.g. total contact cast.

Technical specs

CSV column name:

offloading_using_a_belowknee_cast

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Off-loading using a non-removable knee-high device

Help

E.g. Diabetic Walker rendered non-removable by wrapping it with fibreglass cast material.

Technical specs

CSV column name:

offloading_using_a_nonremovable_kneehigh_device

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

Off-loading using a removable knee-high device

Help

E.g. Diabetic Walker.

Technical specs

CSV column name:

offloading_using_a_removable_kneehigh_device

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Off-loading using an ankle-high cast

Help

E.g. scotch-cast boot.

Technical specs

CSV column name:

offloading_using_an_anklehigh_cast

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Off-loading using a shoe

Help

E.g. Barouk shoe.

Technical specs

CSV column name:

offloading_using_a_shoe

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicalDevice

Data element:

ProductType

choice

Off-loading around the ulcer

Help

E.g. felted foam, silicone orthosis, ...

Technical specs

CSV column name:

offloading_around_the_ulcer

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

MedicalDevice::MedicalDevice

number

Total number of weeks during which the lower leg was immobilized before the patient was allowed to walk with adapted footwear

Help

If periods with immobilization were alternated with periods without immobilization, then sum all periods of immobilization. The number you specify must be an integer.

Technical specs

CSV column name:

total_number_of_weeks_during_which_the_lower_leg_was_immobilized_before_the_patient_was_allowed_to_walk_with_adapted_footwear

Length:

Only when:

Required:

false

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureStartDate

Validation

Total number of weeks during which the lower leg was immobilized before the patient was allowed to walk with adapted footwear: must be an integer (error)
The total duration of immobilization cannot be less than 0 weeks (error)
The total duration of immobilization is greater than 31 weeks. This implies a follow-up duration in IQED-Foot of more than 7 months, which is not allowed. Please check your answer. (warning)

choice

A podiatrist was involved in fitting the off-loading device

Help

Fitting should be interpreted as applying the device and making sure that it fits and is capable of pressure redistribution

Technical specs

CSV column name:

a_podiatrist_was_involved_in_fitting_the_offloading_device

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

4.3 Vascular exams

choice

Clinical investigation of foot pulses

Help

Palpation of the foot pulses

Technical specs

CSV column name:

CD_CLIN_INVSTG_FT_PLS

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

Arterial Doppler exam

Help

Using a hand-held Doppler probe.

Technical specs

CSV column name:

arterial_doppler_exam

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

choice

Determination of ABI

Help

ABI = ankle-brachial index

Technical specs

CSV column name:

determination_of_abi

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Toe pressure measurement

Technical specs

CSV column name:

toe_pressure_measurement

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

TcpO2 measurement

Help

TcpO2 = transcutaneous oxygen pressure

Technical specs

CSV column name:

tcpo2_measurement

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Arterial duplex exam

Help

An arterial duplex exam performed in the 6 months BEFORE inclusion in IQED-Foot is also eligible. An arterial duplex exam implies an exam that visualizes the arterial tree. It does not include exams consisting solely of the interpretation or analysis of audible Doppler signals or arterial waveforms.

Technical specs

CSV column name:

arterial_duplex_exam

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Diagnostic angiography

Help

An angiography performed in the 6 months BEFORE inclusion in IQED-Foot is also eligible. Both conventional angiography as well as CT or MR angiography are eligible. A peroperative angiography is NOT eligible.

Technical specs

CSV column name:

CD_DIAGN_ANGIO

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

4.4 Revascularization of the lower limb

Section help

Only register revascularizations that are ipsilateral to the index foot problem.

choice

Revascularization by endovascular treatment

Help

E.g. balloon dilatation/stent, cryo, laser, …

Technical specs

CSV column name:

revascularization_by_endovascular_treatment

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Revascularization by open surgery

Technical specs

CSV column name:

revascularization_by_open_surgery

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Revascularization at aortoiliac level

Technical specs

CSV column name:

revascularization_at_aortoiliac_level

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Revascularization at femoropopliteal level

Technical specs

CSV column name:

revascularization_at_femoropopliteal_level

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Revascularization at infrapopliteal level

Technical specs

CSV column name:

revascularization_at_infrapopliteal_level

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

4.5 Orthopedic surgery

Section help

Only register orthopedic surgery that is ipsilateral to the index foot problem.

choice

Surgical debridement in operating room

Help

This does not include sharp debridement performed in the out-patient setting.

Technical specs

CSV column name:

surgical_debridement_in_operating_room

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Minor amputation

Help

An amputation below the ankle, i.e. after which heel support is still possible. Classify ankle disarticulation (Syme’s amputation) as a minor amputation.

Technical specs

CSV column name:

minor_amputation

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Was the minor amputation limited to only one or multiple toes?

Help

See toe regions in the figure 'Location of the diabetic foot wound'. If a metatarsal head or other more proximal part of the foot has been amputated, please answer 'No'.

Technical specs

CSV column name:

CD_MINR_AMP_TOES

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

choice

Major amputation

Help

An amputation above the ankle, i.e. after which heel support is no longer possible.

Technical specs

CSV column name:

major_amputation

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

Validation

The date of major amputation cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of major amputation cannot be greater than 215 days (7 months) (error)
The date of major amputation cannot fall after the date of death (error)
A patient with a bilateral major amputation no longer has feet and therefore cannot be included for IQED-Foot. (error)
The date of major amputation falls after the date of healing of the index lesion. Please check your answers. (warning)
You have indicated that the index lesion is of Wagner grade 5 (gangrene of the entire foot), but you did not indicate that the patient received a major amputation. Because this is unlikely, please check your answers. (warning)
The date of major amputation falls after the date of the last contact. Please check whether there has not been a later contact, after the major amputation but before the end of the maximal follow-up period of 7 months. If this is the case, please also make the necessary changes to section 5 (Evolution and outcome). (warning)
You have indicated that the patient received a major amputation during follow-up, but you did not provide the date of major amputation. Please try to provide this date. (warning)
The difference between the date of major amputation and the date of healing of the amputation stump is less than 7 days. Please check whether the provided dates are correct. (warning)

Nested option fields

When 1 Is selected:
date
Date of major amputation
Technical specs
Format:
DD/MM/YYYY
CSV column name:
major_amputation|date_of_major_amputation
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.Procedure
Data element:
ProcedureStartDate

choice

Surgical off-loading to promote ulcer healing and/or prevention

Help

E.g. Achilles tendon lengthening, tenotomy, metatarsal head resection, ...

Technical specs

CSV column name:

surgical_offloading_to_promote_ulcer_healing_andor_prevention

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

choice

Specific Charcot surgery

Help

Charcot surgery = exostectomie and/or reconstructive surgery

Technical specs

CSV column name:

specific_charcot_surgery

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

ProcedureType

5 Evolution and outcome until the last contact with a member of your diabetic foot clinic

Section help

In this section, only include information available up to the last contact with a member of your diabetic foot clinic. Exception: vital status and date of death can be completed after the date of last contact.

date

Date of the LAST contact with a member of your diabetic foot clinic during the follow-up period of max. 7 months

Help

The last contact can be during out-patient consultations or in one of your hospital’s wards (for in-patients) or even in the emergency department.
If the patient was followed-up for > 6 months, please enter the date of the contact that is closest to a follow-up period of 6 months (with a maximum of 7 months). If there was just one contact with the patient, or the interval between the first and second contact was more than 7 months, please enter the date of the FIRST contact.

Technical specs

Format:

DD/MM/YYYY

CSV column name:

date_of_the_last_contact_with_a_member_of_your_diabetic_foot_clinic_during_the_followup_period_of_max_7_months

Required:

true

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Encounter

Data element:

EndDateTime

Validation

The date of the last contact cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the last contact cannot be greater than 215 days (7 months) (error)
The date of the last contact cannot fall after the end date of the audit period (error)
The date of diagnosis of diabetes cannot fall after the date of the last contact (error)
The date of major amputation falls after the date of the last contact. Please check whether there has not been a later contact, after the major amputation but before the end of the maximal follow-up period of 7 months. If this is the case, please also make the necessary changes to section 5 (Evolution and outcome). (warning)
The date of healing falls after the date of the last contact. Please check whether there has not been a later contact, after healing but before the end of the maximal follow-up period of 7 months. If this is the case, please also make the necessary changes to section 5 (Evolution and outcome). (warning)

5.1 Vital status

Section help

If the patient died during the follow-up period, please indicate this in section 1 General patient characteristics at inclusion

5.2 Outcome of the index foot problem

Section help

Note that follow-up in IQED-Foot should not stop when the index foot problem is resolved. Rather, it should continue until the last contact during the follow-up period of max. 7 months.

choice

The index diabetic foot lesion or stump/scar of the minor or major amputation healed during follow-up

Help

Healing = complete epithelialization of the lesion or amputation stump.

Technical specs

CSV column name:

CD_LESION_HEALED_FU

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

Validation

The date of healing cannot fall after the date of death (error)
The date of healing cannot fall before the date of the first contact (error)
The difference between the date of the first contact and the date of healing cannot be greater than 215 days (7 months) (error)
The date of major amputation falls after the date of healing of the index lesion. Please check your answers. (warning)
The date of healing falls after the date of the last contact. Please check whether there has not been a later contact, after healing but before the end of the maximal follow-up period of 7 months. If this is the case, please also make the necessary changes to section 5 (Evolution and outcome). (warning)
You have indicated that the index diabetic foot lesion healed during follow-up, but you did not provide the date of healing. Please try to provide this date. (warning)
You have not indicated whether the index diabetic foot lesion healed during follow-up. Because this is one of the major outcomes studied in IQED-Foot, please try to complete this information. (warning)
The date of healing falls on the date of the first contact. This is not allowed. If the lesion was healed at the time of inclusion, then it should not be included for registration in IQED-Foot. (error)
The difference between the date of major amputation and the date of healing of the amputation stump is less than 7 days. Please check whether the provided dates are correct. (warning)
You have indicated that the index lesion relapsed after healing and that a new ipsilateral lesion occurred during follow-up. If they are the same lesion, then answer "no" on the question "new ipsilateral diabetic foot lesion". (warning)

Nested option fields

When 1 Is selected:
date
Date of healing
Technical specs
Format:
DD/MM/YYYY
CSV column name:
CD_LESION_HEALED_FU|date_of_healing
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.Problem
Data element:
ProblemStatusDate
choice
After healing, the index diabetic foot lesion relapsed
Help
Relapse = lesion at the same location before the end of the maximal follow-up period of 7 months.
Technical specs
CSV column name:
CD_LESION_HEALED_FU|after_healing_the_index_diabetic_foot_lesion_relapsed
Default value:
9
Required:
false
Options
Label Value
No 0
Yes 1
No response 9
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.Problem
Data element:

choice

The active Charcot foot cooled down during follow-up

Help

Cooled down = disappearance of signs of inflammation (redness, swelling) and of the temperature difference with the contralateral foot (difference < 2 °C)

Technical specs

CSV column name:

the_active_charcot_foot_cooled_down

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemStatus

Nested option fields

When 1 Is selected:
choice
After cooling down the Charcot foot reactivated
Help
Reactivation = reappearance of signs of inflammation before the end of the maximal follow-up period of 7 months.
Technical specs
CSV column name:
the_active_charcot_foot_cooled_down|after_cooling_down_the_charcot_foot_reactivated
Default value:
9
Required:
false
Options
Label Value
No 0
Yes 1
No response 9

5.3 New diabetic foot problems that occurred during follow-up

Section help

New = not present at the time of inclusion. Only include new foot problems present before or on the date of the last consultation.

choice

Progressive deformation of the Charcot foot

Technical specs

CSV column name:

progressive_deformation_of_the_charcot_foot

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

New ipsilateral diabetic foot lesion

Technical specs

CSV column name:

new_ipsilateral_diabetic_foot_lesion

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

Validation

You have indicated that the index lesion relapsed after healing and that a new ipsilateral lesion occurred during follow-up. If they are the same lesion, then answer "no" on the question "new ipsilateral diabetic foot lesion". (warning)

choice

New ipsilateral diabetic foot lesion ON a Charcot pressure point

Technical specs

CSV column name:

new_ipsilateral_diabetic_foot_lesion_on_a_charcot_pressure_point

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

New ipsilateral diabetic foot lesion OUTSIDE a Charcot pressure point

Technical specs

CSV column name:

new_ipsilateral_diabetic_foot_lesion_outside_a_charcot_pressure_point

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

New contralateral diabetic foot lesion

Technical specs

CSV column name:

new_contralateral_diabetic_foot_lesion

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

At the end of follow-up both feet were free of active diabetic foot lesions

Help

No more active lesions of Wagner grade 1 or higher on any of the feet at the time of the last contact with a member of your diabetic foot clinic. Also answer "yes" if possible new lesions or relapses that occurred DURING follow-up (registered in the questions above) were healed by the END of follow-up.

Technical specs

CSV column name:

at_the_end_of_followup_both_feet_were_free_of_active_diabetic_foot_lesions

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

choice

New ipsilateral active Charcot (or reactivation)

Technical specs

CSV column name:

new_ipsilateral_active_charcot_or_reactivation

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

choice

New contralateral active Charcot (or reactivation)

Technical specs

CSV column name:

new_contralateral_active_charcot_or_reactivation

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1
No response	9

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Problem

Data element:

ProblemName

6 Secondary prevention

choice

Podiatric follow-up was foreseen after resolution of the index foot problem

Help

Resolution = healed index diabetic foot lesion and/or cooled down index active Charcot foot

Technical specs

CSV column name:

podiatric_followup_was_foreseen_after_resolution_of_the_index_foot_problem

Default value:

Only when:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.PlannedCareActivity

Data element:

OrderStatus

choice

A podiatrist was involved in diagnostic procedures aimed at secondary prevention

Help

E.g. biomechanical assessment (= gait analysis) or clinical exam of mobility and muscle tone.

Technical specs

CSV column name:

a_podiatrist_was_involved_in_diagnostic_procedures_aimed_at_secondary_prevention

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

Performer::HealthProfessional

choice

Adapted footwear for prevention was provided

Help

"Provided" means: the patient now owns the footwear, or measurements were taken and the footwear is currently being fabricated.

Technical specs

CSV column name:

adapted_footwear_for_prevention_was_provided

Default value:

Required:

false

Options

Label	Value
No	0
No, but adapted footwear was acquired less than 2 years ago	1
Yes	2

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.MedicalDevice

Data element:

ProductType

Validation

Pairs of orthopedic shoes: must be an integer (error)
Pairs of semi-orthopedic shoes WITH individualised insoles: must be an integer (error)
Pairs of semi-orthopedic shoes WITHOUT individualised insoles: must be an integer (error)
Pairs of separately prescribed insoles for off-the-rack shoes: must be an integer (error)
You have specified that the provided footwear was adapted for indoor use, but you have registered no or only 1 pair of footwear. Because it is likely that this 1 pair of footwear was provided for OUTDOOR use, we invite you to check your answers. (warning)

Nested option fields

When 2 Is selected:
number
Pairs of orthopedic shoes
Help
The number you specify must be an integer.
Technical specs
CSV column name:
adapted_footwear_for_prevention_was_provided|pairs_of_orthopedic_shoes
Length:
2
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicalDevice
Data element:
ProductType
number
Pairs of semi-orthopedic shoes WITH individualised insoles
Help
The number you specify must be an integer.
Technical specs
CSV column name:
adapted_footwear_for_prevention_was_provided|pairs_of_semiorthopedic_shoes_with_individualised_insoles
Length:
2
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicalDevice
Data element:
ProductType
number
Pairs of semi-orthopedic shoes WITHOUT individualised insoles
Help
The number you specify must be an integer.
Technical specs
CSV column name:
adapted_footwear_for_prevention_was_provided|pairs_of_semiorthopedic_shoes_without_individualised_insoles
Length:
2
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicalDevice
Data element:
ProductType
number
Pairs of separately prescribed insoles for off-the-rack shoes
Help
The number you specify must be an integer.
Technical specs
CSV column name:
adapted_footwear_for_prevention_was_provided|pairs_of_separately_prescribed_insoles_for_offtherack_shoes
Length:
2
Required:
false
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicalDevice
Data element:
ProductType
choice
The provided footwear includes footwear specifically adapted for indoor use
Technical specs
CSV column name:
adapted_footwear_for_prevention_was_provided|the_provided_footwear_includes_footwear_specifically_adapted_for_indoor_use
Default value:
0
Required:
false
Options
Label Value
No 0
No, but adapted footwear was acquired less than 2 years ago 1
Yes 2
Mapping of the clinical building blocks (indicative only)
Concept:
be.en.hd.MedicalDevice
Data element:
ProductType

choice

Digital orthotics in silicone were provided

Help

"Provided" means: the patient now owns the orthotics, or measurements were taken and the orthotics are currently being fabricated.

Technical specs

CSV column name:

digital_orthotics_in_silicone_were_provided

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1

Mapping of the clinical building blocks (indicative only)

Concept:

be.en.hd.Procedure

Data element:

Performer::HealthProfessional

choice

A podiatrist was involved in fitting of preventive footwear

Help

Fitting should be interpreted as applying the footwear and making sure that it fits and is capable of pressure redistribution

Technical specs

CSV column name:

a_podiatrist_was_involved_in_fitting_of_preventive_footwear

Default value:

Required:

false

Options

Label	Value
No	0
Yes	1