Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Status Completed

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00013299
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	Phase 2
Start date	October 2000
Completion date	April 2001

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See also
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