Orthotic Treatment of Diabetic Foot Ulcers
Completed · Not applicable
Conditions studied: Diabetic Foot Ulcer
In brief
The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.
Key facts
- Study ID
- NCT05094037
- Run by
- VA Office of Research and Development
- People needed
- 18
- Starts
- 2023-12-04
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.
You may not qualify if…
- Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
- All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)
- scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded
Where it is running
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
Full record on ClinicalTrials.gov
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