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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05094037
Other study ID # A3781-R
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2023
Est. completion date March 31, 2026

Study information

Verified date December 2023
Source VA Office of Research and Development
Contact Muturi G Muriuki, PhD
Phone (708) 202-5788
Email Muturi.Muriuki@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 175
Est. completion date March 31, 2026
Est. primary completion date September 2, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Country Name City State
United States Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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