Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Leg Ulcer; Ulcer
Intervention: doxycycline; placebo gel
Intervention description: 1.0% doxycycline gel applied topically to the wound once daily for 20 weeks; placebo gel applied topically to the wound once daily for 20 weeks
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic; Ulcer; Wound

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.
    

Eligibility criteria:

        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)