MedTrace Logo

Orthotic Treatment of Diabetic Foot Ulcers

NCT05094037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Muturi G. Muriuki, PhD · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-02-28
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05094037 on ClinicalTrials.gov