Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Ulcer Wound
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief 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.

Detailed description:
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.

Arms:
arm 1: 1.0% doxycycline gel arm 2: placebo gel

Interventions: intervention 1: doxycycline intervention 2: placebo gel
Intervention descriptions: intervention 1: 1.0% doxycycline gel applied topically to the wound once daily for 20 weeks intervention 2: placebo gel applied topically to the wound once daily for 20 weeks

Protocol document: