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Exercise without weight may speed up diabetic foot ulcer healing

NCT ID NCT05603273

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests whether a 6-week program of non-weight bearing exercise can help diabetic foot ulcers heal faster than standard wound care alone. Forty adults with type 2 diabetes and a foot ulcer will be randomly assigned to exercise plus standard care or standard care only. Researchers will measure changes in wound size, blood flow, and metabolism.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
non-weight bearing exercise
What this could lead to
If it works, this could offer a simple, drug-free way to help diabetic foot ulcers heal faster.
What could go wrong
This is a small, early-phase study with only 40 participants. The exercise program may not speed up healing, and results may not apply to everyone with diabetic foot ulcers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

3 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or Female, aged 18 yrs or older 4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes 5. Foot ulcer of diabetic etiology, with all of the following characteristics: * Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer * Ulcer with Wagner grade 1 or 2 6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria. Exclusion Criteria: 1. Patient participating in an interventional clinical trial within 1 month of visit 1 2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading 3. Participant has active severe infection or osteomyelitis at the time of the screening visit 4. History of cancer within the last 3 years, other than non-melanoma skin cancer 5. Use of adjunctive therapy within previous 30 days 6. Currently receiving medication considered to be a systemic glucocorticoid 7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention 8. Pregnant or currently lactating 9. Uncontrolled blood glucose with presence of urinary ketones 10. Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\] 11. Bilateral wound or ulcer 12. Current infection of COVID19 13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study

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Conditions

The condition(s) this trial relates to.

Foot Ulcer type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Foot ulcer TYPE2DIABETES

Contacts and locations

Locations

  • School of Kinesiology

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.