Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
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.