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Walking boot boost: extra encouragement may heal diabetic foot ulcers faster

NCT ID NCT05094037

Disease control Sponsor: VA Office of Research and Development 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving extra education and encouragement to diabetic foot ulcer patients helps them wear their prescribed walking boot more often. The boot is standard care, but many patients don't wear it enough. The study enrolled 18 veterans and measured boot wear time, ulcer size, and healing. The goal is to improve healing and quality of life while reducing costly complications.

What this could mean

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

Active substance
Removable cam walker boot and counseling
What this could lead to
If successful, this could show that extra education and encouragement helps patients wear their boot more, potentially speeding ulcer healing and reducing recurrence.
What could go wrong
This is a small, completed study with only 18 participants, so results may not apply broadly. The intervention is behavioral, so individual adherence may vary.

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

18 people

The number who actually took part.

Started

Dec 2023

Finished

Mar 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study. Exclusion Criteria: * Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded * All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS) * scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded

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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

Contacts and locations

Locations

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612, United States

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