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Orthotics
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each clinic visit through study completion, an average of 8 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Foot ulcer healing status
Foot ulcer size
Number of foot ulcers
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment groupExperimental Treatment2 Interventions
Patients will be given additional counseling
Group II: Control groupActive Control1 Intervention
Patients will be given standard of care.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,830 Total Patients Enrolled
6 Trials studying Foot Ulcer
1,002 Patients Enrolled for Foot Ulcer
Muturi G. Muriuki, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran with a detectable pulse in my feet.I am a veteran, but my wound severity score is less than 4.I am a veteran without a severe infection.I am not a veteran unable to walk.Veterans who are using a special walking boot for their diabetic foot ulcer can join the study.My score is above 7.If you score between 12 and 8, you may need extra help to understand the instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research being actively recruited for?
"As per the records on clinicaltrials.gov, this particular research endeavour is not currently enrolling participants; it was initially posted in early January of 2023 and last updated by mid-August 2022. However, there are 389 other medical studies actively searching for candidates at present."
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