An interventional study of RCW design form in Diabetes Mellitus and Foot Ulcer, sponsored by Rosalind Franklin University of Medicine and Science. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: RCW design form
Device: RCW design form
Tall RCW= a knee high removable cast walker with an offloading insole Short RCW= an ankle high (extending up the leg just past the ankle) removable cast walker with an offloading insole, paired with an external shoe lift to be used with a diabetic shoe on the contralateral limb
Offloading adherence
Percent of weight bearing activity completed while wearing the RCW
Time frame: days 0-28
Diabetic Foot Ulcer Healing
Planimetric wound area
Time frame: each clinical visit during days 0-28
Cumulative plantar tissue stress
A measure to account for the interaction between offloading capacity of the RCW and device use
Time frame: days 0-28
Stability
three separate measures taken during walking and standing (local divergence exponent of he trunk; motor equivalent index during small standing perturbations; and posterior stepping threshold for large perturbations while standing)
Time frame: follow up visit (32-38 days after baseline)
Correlates of joint pain
Four separate biomechanical measures related to back, hip and knee pain taken during walking in a motion capture lab (peak pelvic obliquity; peak pelvic tilt; ground reaction force transience; and rate of grand reaction force loading)
Time frame: follow up visit (32-38 days after baseline)
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Rosalind Franklin University of Medicine and Science