Orthotic Treatment of Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT05094037
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-26
• Study Start: 2023-12-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-09-02
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Orthosis wear-time	At each clinic visit through study completion, an average of 8 months	The total time that the orthosis has been worn between clinic visits.
Foot ulcer size	At each clinic visit through study completion, an average of 8 months	Size of the diabetic foot ulcer.
Foot ulcer healing status	At each clinic visit through study completion, an average of 8 months	Status of the diabetic foot ulcer.
Number of foot ulcers	At each clinic visit through study completion, an average of 8 months	The number of diabetic foot ulcers.

Trial Locations

Locations (1)

Edward Hines Jr. VA Hospital, Hines, IL; 🇺🇸 Hines, Illinois, United States