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

Launched by ROSALIND FRANKLIN UNIVERSITY OF MEDICINE AND SCIENCE · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the design of a special walking boot, called a removable cast walker (RCW), affects how well patients with diabetic foot ulcers heal. Diabetic foot ulcers are sores that can develop on the feet of people with diabetes, and if not treated properly, they can lead to serious complications, including amputation. The researchers want to see if different designs of these walking boots make it easier for patients to wear them as instructed, which is important for healing. They will also look at how the boot feels to wear, which might impact how often patients use it.

To participate in this study, you need to have a specific type of diabetic foot ulcer that is being treated by a healthcare professional, and you should be able to walk for at least two minutes at your own pace. However, some people won't be eligible, such as those who have had more serious foot surgeries or have certain medical conditions that affect their feet or balance. If you join this study, you will help researchers gather important information that could lead to better treatments for diabetic foot ulcers in the future.

Gender

ALL

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