Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
NCT00013299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 427
Last updated 2009-01-21
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.
Conditions
- Diabetic Foot Ulcers
Interventions
- DEVICE
-
Prevention of Diabetic Ulcers
Sponsors & Collaborators
-
US Department of Veterans Affairs
lead FED
Principal Investigators
-
John Fryer, Ph.D. Asst. Director · Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
-
Wijegupta Ellepola, Program Analyst · Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-10-31
- Completion
- 2001-04-30
Countries
- United States
Study Locations
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