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Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

2014-08-27 03:42:07 | BioPortfolio

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.

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

Conditions

Diabetic Foot Ulcer

Intervention

Dermal - Living Skin Replacement (Dermal - LSR)

Location

Southern Arizona Veterans Administration Health Care System, 3601 S. 6th Avenue (2-112)
Tuscon
Arizona
United States
85723

Status

Terminated

Source

ApoPharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:07-0400

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