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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05415878
• Other study ID #: DK131303
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2022
• Source: Rosalind Franklin University of Medicine and Science
• Contact: Noah J Rosenblatt, PhD
• Phone: 8475788425
• Email: noah.rosenblatt[@]rosalindfranklin.edu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	Manchester Metropolitan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stability	three separate measures taken during walking and standing (local divergence exponent of he trunk; motor equivalent index during small standing perturbations; and posterior stepping threshold for large perturbations while standing)	follow up visit (32-38 days after baseline)
Other	Correlates of joint pain	Four separate biomechanical measures related to back, hip and knee pain taken during walking in a motion capture lab (peak pelvic obliquity; peak pelvic tilt; ground reaction force transience; and rate of grand reaction force loading)	follow up visit (32-38 days after baseline)
Primary	Offloading adherence	Percent of weight bearing activity completed while wearing the RCW	days 0-28
Secondary	Diabetic Foot Ulcer Healing	Planimetric wound area	each clinical visit during days 0-28
Secondary	Cumulative plantar tissue stress	A measure to account for the interaction between offloading capacity of the RCW and device use	days 0-28