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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rosalind Franklin University of Medicine and Science is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Started Aug 2023 (actual). Primary completion is estimated for Apr 2027, 44 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 44 months is above that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Rosalind Franklin University of Medicine and Science