Back to resultsClinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
Primary Purpose
Diabetic Foot Ulcers
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prevention of Diabetic Ulcers
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Foot Ulcers focused on measuring Foot ulcers, amputation prevention, diabetes, footwear, insoles
Eligibility Criteria
Diabetics with foot ulcerations
Sites / Locations
- VAMC, Seattle, WA
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013299
First Posted
March 14, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013299
Brief Title
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
Official Title
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
Detailed Description
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Foot ulcers, amputation prevention, diabetes, footwear, insoles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Prevention of Diabetic Ulcers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diabetics with foot ulcerations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D. Asst. Director
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Wijegupta Ellepola, Program Analyst
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Facility Information:
Facility Name
VAMC, Seattle, WA
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
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