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TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Clinical Trial Summary

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

Clinical Trial Description

This study will evaluate the use of TheraGauzeT (Soluble Systems, LLC) wound dressing, a polymer hydrogel chemically impregnated into a rayon/polyester formed fabric, forming a pliable, conforming solid matrix. TheraGauze is FDA Class I exempt (regulation #21CFR, product code 5878.4022). It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers. It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function. This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex. ;

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 NCT00389636
Study type Interventional
Source Soluble Systems, LLC
Contact
Status Active, not recruiting
Phase N/A
Start date September 2006
Completion date July 2008
View Details
See also
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