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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013299
First received: March 14, 2001
Last updated: January 20, 2009
Last verified: January 2001
History of Changes
  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 Intervention Phase
Diabetic Foot Ulcers
 Device: Prevention of Diabetic Ulcers
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 427
Study Start Date: October 2000
Study Completion Date: April 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Diabetics with foot ulcerations

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013299

Locations
United States, Washington
VAMC, Seattle, WA
Seattle, Washington, United States
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Investigator: John Fryer, Ph.D. Asst. Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Wijegupta Ellepola, Program Analyst Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00013299     History of Changes
Other Study ID Numbers: A2443R
Study First Received: March 14, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Foot ulcers, amputation prevention, diabetes, footwear, insoles

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on June 17, 2013