Orthotic Treatment of Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Treatment group

Patients will be given additional counseling

Group Type EXPERIMENTAL

Removable cam walker boot

Intervention Type DEVICE

Standard of care device given to diabetic foot ulcer patients.

Counseling

Intervention Type OTHER

Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.

Control group

Patients will be given standard of care.

Group Type ACTIVE_COMPARATOR

Removable cam walker boot

Intervention Type DEVICE

Standard of care device given to diabetic foot ulcer patients.

Interventions

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Removable cam walker boot

Standard of care device given to diabetic foot ulcer patients.

Intervention Type DEVICE

Counseling

Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No