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

NCT05415878 | Unknown DMC

• 1 other identifier: DK131303
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Offloading adherence

  Percent of weight bearing activity completed while wearing the RCW

  days 0-28

Secondary Outcomes (2)

• Diabetic Foot Ulcer Healing

  each clinical visit during days 0-28

• Cumulative plantar tissue stress

  days 0-28

Other Outcomes (2)

• Stability

  follow up visit (32-38 days after baseline)

• Correlates of joint pain

  follow up visit (32-38 days after baseline)

Study Arms (2)

Tall RCW

OTHER

Device: RCW design form

Short RCW with contralateral lift

OTHER

Device: RCW design form

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

Short RCW with contralateral lift; Tall RCW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead
• Manchester Metropolitan University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Noah J Rosenblatt, PhD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah J Rosenblatt, PhD

CONTACT

8475788425; noah.rosenblatt@rosalindfranklin.edu

Ryan Crews, PhD

CONTACT

ryan.crews@rosalindfranklin.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 13, 2022

Record last verified: 2022-06