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Can a better boot heal diabetic foot ulcers faster?

NCT ID NCT05415878

Symptom relief Sponsor: Rosalind Franklin University of Medicine and Science Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This pilot study investigates how the design of removable cast walkers—used to offload diabetic foot ulcers—affects how often patients wear them and how well the ulcers heal. Researchers will compare a knee-high walker with an ankle-high version paired with a shoe lift, measuring adherence, biomechanical factors, and patient-reported usability. The goal is to gather feasibility data for a larger trial that could improve ulcer healing and reduce amputation risk.

What this could mean

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

Active substance
removable cast walker (RCW) with offloading insole
What this could lead to
If successful, this could guide better walker designs that improve adherence and healing for diabetic foot ulcers, potentially reducing amputations.
What could go wrong
This is a small pilot study, so results may not be conclusive. The walkers' effectiveness depends on user adherence, which may still be low despite design changes.

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 40 people

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

Started

Aug 2023

Expected to finish

May 2027

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

18 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: * presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that is being treated on an outpatient basis with a University of Texas wound classification of 1A-C or 2 A-C; * self-reported ability to walk for at least two continuous minutes at a self-selected speed * confirmation of the presence of diabetic peripheral neuropathy as identified by failure to detect a 10 gram Semmes Weinstein Monofilament on either foot at one of four sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) OR a vibration perception threshold value of 25 or more at either hallux. Exclusion Criteria: * lower extremity amputation more proximal than transmetatarsal on either limb * chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or eGFR\<30 within last 60 days) * active Charcot neuroarthropathy * severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalis pedis arteries, and an ankle brachial index\<0.7) * gait/balance disturbance not attributable to diabetes (e.g. neuromuscular disease or cerebrovascular vascular accident) * current or previous (within past year) use of an ankle-high RCW or of a contralateral lift to offset an RCW-induced LLD

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Foot Ulcer

As listed by the trial registrant

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

Diabetes mellitus Foot ulcer

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rosalind Franklin University of Medicine and Science

    RECRUITING

    North Chicago, Illinois, 60064, United States

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