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.
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)
