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Clinical Trials of Footwear in Patients with Diabetes-Study Arm 2,3
This study is no longer recruiting patients.
Sponsored by: | Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Diabetic Foot Ulcers |
Device: Prevention of Diabetic Ulcers |
Phase II |
MedlinePlus related topics: Diabetic Foot
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Expected Total Enrollment: 427
Study start: October 2000;
Study completion: April 2001
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Location Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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