Orthotic Treatment of Diabetic Foot Ulcers

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Device: Removable cam walker boot
* Other: Counseling


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients will be given additional counseling | Device: Removable cam walker boot<br>* Standard of care device given to diabetic foot ulcer patients.<br>Other: Counseling<br>* Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.<br>|
| Active Comparator: Control group<br>Patients will be given standard of care. | Device: Removable cam walker boot<br>* Standard of care device given to diabetic foot ulcer patients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Foot ulcer size | Size of the diabetic foot ulcer. | At each clinic visit through study completion, an average of 8 months | 
| Foot ulcer healing status | Status of the diabetic foot ulcer. | At each clinic visit through study completion, an average of 8 months | 
| Number of foot ulcers | The number of diabetic foot ulcers. | At each clinic visit through study completion, an average of 8 months |