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Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:
Pivotal Study to Evaluate the Efficacy and Safety of Dermal - Living Skin Replacement (Dermal - LSR) in the Treatment of Chronic Diabetic Foot Ulcers

Clinical Trial Summary

The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.

Clinical Trial Description

This prospective, randomized, controlled, open-label, multi-center study will test the efficacy of Dermal - Living Skin Replacement (Dermal - LSR) plus standard of care treatment against solely the standard of care treatment on participants with diabetic foot ulcers.

The purpose of this study is to test Dermal - LSR combined with standard treatment. We want to see how well it works and the number and types of side effects, if any. We hope to learn more about how to heal diabetic foot ulcers better.

You will:

- be interviewed and examined

- have weekly clinic visits

- have blood drawn

- have the ulcer photographed

- wear a walking boot to reduce pressure on the ulcer ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00368693
Study type Interventional
Source University of California, Davis
Contact
Status Terminated
Phase Phase 3
Start date August 2005
Completion date September 2007
View Details
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