Orthotic Treatment of Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removable cam walker boot
Counseling
Sponsored by
About this trial
This is an interventional other trial for Diabetic Foot Ulcer
Eligibility Criteria
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
Sites / Locations
- Edward Hines Jr. VA Hospital, Hines, IL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Patients will be given additional counseling
Patients will be given standard of care.
Outcomes
Primary Outcome Measures
Orthosis wear-time
The total time that the orthosis has been worn between clinic visits.
Foot ulcer size
Size of the diabetic foot ulcer.
Foot ulcer healing status
Status of the diabetic foot ulcer.
Number of foot ulcers
The number of diabetic foot ulcers.
Secondary Outcome Measures
Full Information
NCT ID
NCT05094037
First Posted
October 22, 2021
Last Updated
June 1, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05094037
Brief Title
Orthotic Treatment of Diabetic Foot Ulcers
Official Title
Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 2, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients will be given additional counseling
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will be given standard of care.
Intervention Type
Device
Intervention Name(s)
Removable cam walker boot
Intervention Description
Standard of care device given to diabetic foot ulcer patients.
Intervention Type
Other
Intervention Name(s)
Counseling
Intervention Description
Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.
Primary Outcome Measure Information:
Title
Orthosis wear-time
Description
The total time that the orthosis has been worn between clinic visits.
Time Frame
At each clinic visit through study completion, an average of 8 months
Title
Foot ulcer size
Description
Size of the diabetic foot ulcer.
Time Frame
At each clinic visit through study completion, an average of 8 months
Title
Foot ulcer healing status
Description
Status of the diabetic foot ulcer.
Time Frame
At each clinic visit through study completion, an average of 8 months
Title
Number of foot ulcers
Description
The number of diabetic foot ulcers.
Time Frame
At each clinic visit through study completion, an average of 8 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muturi G Muriuki, PhD
Phone
(708) 202-5788
Email
Muturi.Muriuki@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Havey, MS
Phone
(708) 202-3781
Email
Robert.Havey@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muturi G. Muriuki, PhD
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muturi G Muriuki, PhD
Phone
708-202-5788
Email
Muturi.Muriuki@va.gov
First Name & Middle Initial & Last Name & Degree
Muturi G. Muriuki, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Orthotic Treatment of Diabetic Foot Ulcers
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