Can a better boot heal diabetic foot ulcers faster?

NCT ID NCT05415878

This trial is taking on new participants right now.

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.

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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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Rosalind Franklin University of Medicine and Science

    RECRUITING

    North Chicago, Illinois, 60064, United States

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