Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers

Part of paid clinical trials in North Chicago, Illinois.

Sponsor
Rosalind Franklin University of Medicine and Science
Study ID
NCT05415878
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Foot Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RCW design form — DEVICE
    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

Study Details

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.

Key Dates

First listed
Jun 13, 2022
Start date
Aug 2, 2023
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Tall RCW
  • Other: Short RCW with contralateral lift

Primary Outcome Measure

Offloading adherence [ Time Frame: days 0-28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rosalind Franklin University of Medicine and ScienceNorth ChicagoIllinois60064
Noah J Rosenblat, PhD

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Rosalind Franklin University of Medicine and Science· North Chicago, IL

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