Orthotic Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094037
• Other study ID #: A3781-R
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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