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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcers

• Registration Number: NCT00013299
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2000-10
• Status Verified: 2001-01
• Study First Submitted: 2001-03-14
• Study First Submitted QC: 2001-03-15
• Study First Posted: 2001-03-16
• Study Completion: 2001-04
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

VAMC, Seattle, WA; 🇺🇸 Seattle, Washington, United States