NCT05094037

Orthotic Treatment of Diabetic Foot Ulcers

Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Removable cam walker boot	Standard of care device given to diabetic foot ulcer patients.
OTHER	Counseling	Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-02-28
• Completion: 2026-03-31
• First posted: 2021-10-26
• Last updated: 2026-03-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study