Recruiting

Removable Cast Walkers

Sponsor:

Rosalind Franklin University of Medicine and Science

Code:

NCT05415878

Conditions

Diabetes Mellitus

Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RCW design form

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus

Foot Ulcer

Study ID

NCT05415878

Start date

Aug 2, 2023

Status verified date

Aug, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Tall RCW

other: Short RCW with contralateral lift

Interventions

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

Primary outcome measure

  • Offloading adherence [ Time Frame: days 0-28 ]

Central Contacts and Locations

Central contacts

Noah J Rosenblatt, PhD

8475788425noah.rosenblatt@rosalindfranklin.edu

Ryan Crews, PhD

ryan.crews@rosalindfranklin.edu

Locations

Rosalind Franklin University of Medicine and Science

Recruiting

North Chicago, Illinois, United States, 60064

More Information

Sponsor

Rosalind Franklin University of Medicine and Science

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rosalind Franklin University of Medicine and Science on 2026-08-19.