Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Key facts
- Who runs it
- Rosalind Franklin University of Medicine and Science
- Where
- North Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 2 Aug 2023
- Expected to end
- 30 May 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- RCW design form
- Record updated
- 19 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- current or previous (within past year) use of an ankle-high RCW or of a contralateral lift to offset an RCW-induced LLD
- 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)
- chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or eGFR<30 within last 60 days)
- lower extremity amputation more proximal than transmetatarsal on either limb
- active Charcot neuroarthropathy
Where in United States
- Rosalind Franklin University of Medicine and ScienceNorth Chicago, United StatesContact: Noah J Rosenblat, PhDTaking people
About the trial
What the trial wants to find out
Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. While RCWs are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. This is a serious concern given that low adherence predicts poor DFU healing. This study will provide pilot/feasibility data to inform a larger clinical trial to evaluate the impact of existing RCW designs on adherence and DFU healing. We will also quantify the effect of RCW form on biomechanical and self-reported measures related to usability. Our working hypothesis is that healing outcomes with a given RCW will be predicted by biomechanical and self-reported measures of RCW usability, with the predictive relationship partly explained by the effect of these measures on adherence.
The 2 groups in the trial
- Tall RCWOther group
Treatment: RCW design form
- Short RCW with contralateral liftOther group
Treatment: RCW design form
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Improving Diabetic Foot Ulcer Offloading: A Pilot Study on the Impact of Removable Cast Walker Design Factors on Usability
- Record updated
- 19 August 2026