Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT06092827
Eligibility Criteria:
For individuals with a diabetic foot ulcer:
Inclusion:
* Male or female
* Aged over 18 up to 75 years
* Willing to engage in PA (physical activity)
* Committed to following wound care recommendations to the best of their ability for the duration of the study
* Understand and read French.
Exclusion:
* Uncontrolled DFU infection
* Use of a non-removable offloading modality (total contact cast)
* Uncontrolled hyperglycemia (HbA1c ≥ 10.0% or fasting blood glucose ≥ 16.0 mmol/L for ≥ 2 consecutive days) confirmed by blood sample results during the initial assessment or access to recent blood test results (within the last 3 months) or the log of home capillary blood glucose readings
* Participation in sports or regular intense physical activities (≥ 2 times per week)
* The following pre-existing heart problems: a cardiovascular event (myocardial infarction, heart surgery, etc.) in the last 3 months, unstable cardiovascular disease (uncontrolled hypertension, i.e., ≥ 160/90 mmHg, uncompensated heart failure, etc.), chest pain and exertional dyspnea and/or uninvestigated intermittent claudication
* Recent neurovascular problem (stroke, transient ischemic attack, etc.) in the last 3 months
* Health problem that the research team considers a contraindication to participating in the study
* Diabetes complication making moderate-intensity PA unsafe, such as untreated proliferative diabetic retinopathy or a sensitivity disorder to hypoglycemia, critical ischemia of one or both lower limbs.
For kinesiologists:
Inclusion:
* Have completed a bachelor's degree in kinesiology
* Understand, read, and speak French.
Exclusion:
None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06092827
Study Brief:
Protocol Section:
NCT06092827