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
Diabetic Foot Ulcers	Device: Prevention of Diabetic Ulcers	Phase II

Further Study Details: 

Expected Total Enrollment:  427

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Diabetics with foot ulcerations

Washington
      VAMC, Seattle, WA, Seattle,  Washington,  United States

Study chairs or 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 ID Numbers:  A2443
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00013299
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08