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NCT06312579 · ClinicalTrials.gov registry record · NA

At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers

A NA study, sponsored by VA Office of Research and Development.

Active
Registry status
NA
Development phase
26
Enrollment target

NCT06312579: Active NA study, sponsored by VA Office of Research and Development.

NCT06312579 is a NA study that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06312579, a NA study, is active but no longer recruiting, sponsored by VA Office of Research and Development.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
26 participants
Enrollment target

Study Summary

Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility. People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

Primary Outcome

Usual gait speed will be calculated based on a 10-meter walk distance. The investigators will provide individuals with a 14-meter path for walking to provide room for a "flying start." The participant will walk 14 meters, but gait speed will only be timed during the intermediate 10 meters. This will allow us to determine gait speed without the confounding factor of acceleration and deceleration.

Interventions

  • BEHAVIORAL 12-week home based exercise
  • BEHAVIORAL 12-week standard of care

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2024-10-01
Est. Completion 2027-03-31
Phase NA
VA Office of Research and Development

1,668 total trials

What the registry record for NCT06312579 still lists

NCT06312579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which 12-week home based exercise is the first listed.

NCT06312579 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06312579 about?

NCT06312579 is a clinical study titled "At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers". Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years...

What is the current status of trial NCT06312579?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 26 participants. The study started on 2024-10-01. Estimated completion is 2027-03-31.

What interventions are being tested in trial NCT06312579?

The interventions under investigation include: 12-week home based exercise (BEHAVIORAL), 12-week standard of care (BEHAVIORAL).

Who is sponsoring clinical trial NCT06312579?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06312579's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06312579, the US trial registry maintained by the National Library of Medicine. NCT06312579 (small enrollment · none site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.