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ACTIVE NOT RECRUITING
NCT05094037
NA

Orthotic Treatment of Diabetic Foot Ulcers

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-12-04

Completion Date

2026-03-31

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

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.

Locations (2)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States