Status:
UNKNOWN
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Lead Sponsor:
Rosalind Franklin University of Medicine and Science
Collaborating Sponsors:
Manchester Metropolitan University
Conditions:
Diabetes Mellitus
Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05415878
Start Date
October 1 2022
End Date
August 1 2025
Last Update
June 13 2022
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