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

Diabetes Mellitus Clinical Trial

Official title:
Improving Diabetic Foot Ulcer Offloading: A Pilot Study on the Impact of Removable Cast Walker Design Factors on Usability

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05415878
Study type Interventional
Source Rosalind Franklin University of Medicine and Science
Contact Noah J Rosenblatt, PhD
Phone 8475788425
Email noah.rosenblatt@rosalindfranklin.edu
Status Not yet recruiting
Phase N/A
Start date October 1, 2022
Completion date August 1, 2025
View Details
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