Treatment for diabetic foot ulcers using orthotic boots
Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment
This study tests whether using special walking boots can help veterans with diabetic foot ulcers heal faster and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Hines, Illinois) |
| Trial ID | NCT05094037 on ClinicalTrials.gov |
What this trial studies
This project aims to address the significant healthcare costs associated with diabetic foot ulcers among veterans by utilizing a removable cam walker boot as a treatment method. The intervention focuses on reducing healing time for ulcers, prolonging the intervals between ulcer occurrences, and enhancing the overall quality of life for affected patients. By targeting veteran patients who are prescribed orthotic walking boots, the study seeks to evaluate the effectiveness of this approach in managing a common complication of diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are veteran patients who have been prescribed an orthotic walking boot for their diabetic foot ulcers.
Not a fit: Patients with severe infections, amputations, or those who are non-ambulatory will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing times and quality of life for patients suffering from diabetic foot ulcers.
How similar studies have performed: While similar approaches have been explored, this specific intervention targeting veterans with diabetic foot ulcers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hines, Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Muturi G. Muriuki, PhD — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Muturi G Muriuki, PhD
- Email: Muturi.Muriuki@va.gov
- Phone: (708) 202-5788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.