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

NCT ID: NCT05415878

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-08-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tall RCW

Group Type: OTHER

RCW design form

Intervention Type: 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

Short RCW with contralateral lift

Group Type: OTHER

RCW design form

Intervention Type: 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

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester Metropolitan University

OTHER

Sponsor Role: collaborator

Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role: lead

Responsible Party

Noah Rosenblatt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah J Rosenblatt, PhD

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University of Medicine and Science

Central Contacts

Noah J Rosenblatt, PhD

Role: CONTACT

noah.rosenblatt@rosalindfranklin.edu

8475788425

Ryan Crews, PhD

Role: CONTACT

ryan.crews@rosalindfranklin.edu

Other Identifiers

DK131303

Identifier Type: -

Identifier Source: org_study_id