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

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

Inclusion criteria

• Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association
• Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:

• Agree to use a double-barrier method of contraception during their participation in this study;
• condoms (with spermicide) and hormonal contraceptives OR
• condoms (with spermicide) and intrauterine device OR
• intrauterine device and hormonal contraceptives OR
• Abstains from sexual intercourse during their participation in this study OR
• Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
• Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
• Be able to apply study drug to their ulcer, or have a caregiver do it
• Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
• Target ulcer is Grade I according to the Wagner Grading Scale
• Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers
• Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers

Exclusion criteria

• Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
• Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
• Have more than three chronic ulcers present at baseline
• Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
• Have connective tissue disease
• Currently be going through kidney dialysis for renal failure
• Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days
• Have participated in another clinical research trial within the last 30 days
• Have a known history of osteomyelitis affecting to the area where the target ulcer is present
• Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
• Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)