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Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of NanoDOX™ Hydrogel(1.0% Doxycycline Monohydrate)in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.

Clinical Trial Summary

This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.

Clinical Trial Description

Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00764361
Study type Interventional
Source Nanotherapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date January 2009
Completion date August 2010
View Details
See also
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