Diabetic Foot Ulcer
Conditions
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.
Interventions
DEVICERemovable cam walker boot
Standard of care device given to diabetic foot ulcer patients.
OTHERCounseling
Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orthosis wear-time | At each clinic visit through study completion, an average of 8 months | The total time that the orthosis has been worn between clinic visits. |
| Foot ulcer size | At each clinic visit through study completion, an average of 8 months | Size of the diabetic foot ulcer. |
| Foot ulcer healing status | At each clinic visit through study completion, an average of 8 months | Status of the diabetic foot ulcer. |
| Number of foot ulcers | At each clinic visit through study completion, an average of 8 months | The number of diabetic foot ulcers. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMuturi G. Muriuki, PhD
Edward Hines Jr. VA Hospital, Hines, IL
Outcome results
None listed