NCT05415878

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rosalind Franklin University of Medicine and Science · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-01-01
• Completion: 2025-08-01
• First posted: 2022-06-13
• Last updated: 2022-06-13