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Sponsored by: |
Soluble Systems, LLC |
Information provided by: | Soluble Systems, LLC |
ClinicalTrials.gov Identifier: | NCT00389636 |
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.
Condition | Intervention |
Diabetic Foot Ulcer |
Device: TheraGauze Drug: Regranex |
MedlinePlus related topics: | Diabetic Foot Foot Health |
ChemIDplus related topics: | Becaplermin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers |
Enrollment: | 30 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
TheraGauze alone
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Device: TheraGauze
TheraGauze
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2: Active Comparator
Theragauze + Regranex
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Drug: Regranex
Regranex + TheraGauze
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patients
Exclusion Criteria: Patients
United States, Illinois | |||||
Northwestern University | |||||
Chicago, Illinois, United States, 60611 |
Soluble Systems, LLC |
Principal Investigator: | Anne Laumann, MBChB, MRCP | Northwestern University |
Principal Investigator: | Adam Landsman, DPM, PhD | Northwestern University |
Responsible Party: | Soluble Systems, LLC ( Allan Staley ) |
Study ID Numbers: | SS-0601 |
First Received: | October 18, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00389636 |
Health Authority: | United States: Institutional Review Board |
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