Impact of Removable Cast Walker Design on Usability for DFU Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot/feasibility study explores how various removable cast walker designs affect user-friendly features and adherence in adults with diabetic foot ulcers. The trial will collect biomechanical data and self-reported usability measures, and relate these to adherence and preliminary healing outcomes. It aims to inform a larger future trial by identifying which RCW design aspects support better adherence and healing signals. Participants will wear different RCW forms under supervision and complete usability assessments alongside standard care. Results will help refine RCW selection to improve DFU care.

Why it matters

Who can join: the full rules

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

Where it's running

• Rosalind Franklin University of Medicine and Science
  North Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Noah J Rosenblatt, PhD — Rosalind Franklin University of Medicine and Science
• Study coordinator: Noah J Rosenblatt, PhD
• Email: noah.rosenblatt@rosalindfranklin.edu
• Phone: 8475788425

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.