NCT05094037

Orthotic Treatment of Diabetic Foot Ulcers

Active, enrolled NA Last updated 25 March 2026

What this trial tests

NA trial testing Removable cam walker boot in Diabetic Foot Ulcer in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 December 2023

Primary endpoint
28 February 2026

31 March 2026

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	18
Start date	4 December 2023
Primary completion	28 February 2026
Estimated completion	31 March 2026
Sites	2 locations across United States

Drugs / interventions tested

• Removable cam walker boot
• Counseling

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.