NCT00764361

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NanoSHIFT LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	doxycycline	1.0% doxycycline gel applied topically to the wound once daily for 20 weeks
DRUG	placebo gel	placebo gel applied topically to the wound once daily for 20 weeks

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-10-02
• Last updated: 2017-04-07
• Results posted: 2012-04-05

Locations

1 site across 1 country: United States