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Completed

NCT Number: NCT05094037

Orthotic Treatment of Diabetic Foot Ulcers

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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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesse Brown VA Medical Center, Chicago, IL, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removable cam walker boot

Device

Standard of care device given to diabetic foot ulcer patients.

Counseling

Other

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

Primary outcomes

  1. Orthosis wear-time

    Time frame: At each clinic visit through study completion, an average of 8 months

    The total time that the orthosis has been worn between clinic visits.

  2. Foot ulcer size

    Time frame: At each clinic visit through study completion, an average of 8 months

    Size of the diabetic foot ulcer.

  3. Foot ulcer healing status

    Time frame: At each clinic visit through study completion, an average of 8 months

    Status of the diabetic foot ulcer.

  4. Number of foot ulcers

    Time frame: At each clinic visit through study completion, an average of 8 months

    The number of diabetic foot ulcers.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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