Orthotic Treatment of Diabetic Foot Ulcers

VA Office of Research and Development

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Device: Removable cam walker boot; Other: Counseling

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05094037

A3781-R

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients will be given additional counseling

Treatment:

Other: Counseling

Device: Removable cam walker boot

Control group

Active Comparator group

Description:

Patients will be given standard of care.

Treatment:

Device: Removable cam walker boot