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Efficacy and Safety Study in the Treatment of Chronic 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 determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Clinical Trial Description

The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00387101
Study type Interventional
Source ApoPharma
Contact
Status Terminated
Phase Phase 3
Start date February 2006
Completion date April 2008
View Details
See also
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