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Walking again: exercise trial aims to get diabetic foot ulcer patients back on their feet

NCT ID NCT06894563

Symptom relief Sponsor: University of Maryland, Baltimore 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a 12-week exercise program can safely improve mobility in people aged 50 and older who have recently healed from a diabetic foot ulcer. Participants will either do seated cycling and strength exercises or follow standard care guidance. The goal is to see if the exercise regimen is feasible and helps people walk farther without causing the ulcer to come back.

What this could mean

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

Active substance
12-week exercise regimen (seated cycling and strength/balance exercises)
What this could lead to
If successful, this could provide a safe way for people with healed diabetic foot ulcers to regain mobility and reduce their risk of cardiovascular death.
What could go wrong
This is a small early-stage feasibility trial with only 60 participants, so results may not apply to everyone. The exercise might not improve mobility or could increase the risk of ulcer recurrence.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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

50 years and older

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: * Adults \>= 50 years * Diagnosis of diabetes * Plantar foot ulcer which healed within the last 3-15 months * Two feet (can have healed minor amputations of fore and midfoot) * Willing to wear appropriately fitted footwear for exercise regimen * Ambulatory without walker * Willing to enroll in the PODIMETRICS SmartMat program * Able to give written informed consent Exclusion Criteria: * Unable to perform the exercise interventions (e.g. due to hearing or visual impairment) * Anticipated foot surgery in the next 4 months * Participating in another exercise program * Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene) * Current plantar foot ulcer * Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Diabetic foot ulcer

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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