Exercise without foot pressure: a new path for diabetic ulcer patients?
NCT ID NCT06092827
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This trial tests a 12-week exercise program designed for people with diabetic foot ulcers who must avoid putting weight on their feet. Participants do aerobic, resistance, and flexibility exercises while wearing an offloading device, with two supervised sessions and one home session per week. Researchers measure whether the program is feasible and acceptable, and also track fitness levels and daily step counts. The goal is to see if this approach can help people stay physically active without harming their healing feet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A 12-week non-weight-bearing physical activity program combining aerobic, resistance, and flexibility exercises, with two supervised sessions and one home-based session per week.
- What this could lead to
- If this program proves feasible and acceptable, it could offer a safe way for people with diabetic foot ulcers to stay physically active, potentially improving heart and lung fitness and daily step counts without delaying wound healing.
- What could go wrong
- This is a small feasibility study with only 12 participants, so results may not apply broadly. The program requires commitment to both exercise and wound care, and some people may find it hard to stick with or may not see clear fitness gains.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Universite du Quebec à Trois-Rivieres
Trois-Rivières, Quebec, G8Z 4M3, Canada
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