Orthotic Treatment for Diabetic Foot Ulcers

N/A

Recruiting

Led By Muturi G. Muriuki, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Veteran patients without palpable pedal pulse will be excluded

Veteran patients with a Meggitt-Wagner score of 4 or more will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each clinic visit through study completion, an average of 8 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to heal diabetic foot ulcers that is faster and reduces the chance of the ulcer coming back.

Who is the study for?

This trial is for veteran patients with diabetic foot ulcers who are prescribed an orthotic walking boot. Participants must be able to understand instructions (with a BIMS score above 7), have palpable pedal pulses, and be ambulatory. Those with severe cognitive impairment, serious infections, amputations above the ankle, or very advanced ulcers (Meggitt-Wagner score of 4+) cannot join.

What is being tested?

The study is testing whether using a removable cam walker boot and providing counseling can reduce healing time for diabetic foot ulcers, prevent future ulcers, and improve quality of life compared to standard care alone in veterans.

What are the potential side effects?

Potential side effects may include skin irritation from the boot, discomfort while walking with the orthotic device, or stress due to adherence to treatment protocols. Counseling typically does not have physical side effects but can sometimes bring up emotional issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a veteran with a detectable pulse in my feet.

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I am a veteran, but my wound severity score is less than 4.

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I am a veteran without a severe infection.

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I am not a veteran unable to walk.

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My score is above 7.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each clinic visit through study completion, an average of 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each clinic visit through study completion, an average of 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each clinic visit through study completion, an average of 8 months for reporting.