NCT00013299

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 427 (planned)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Prevention of Diabetic Ulcers

Timeline

• Start date: 2000-10-01
• Completion: 2001-04-01
• First posted: 2001-03-16
• Last updated: 2009-01-21

Locations

1 site across 1 country: United States