Status:
COMPLETED
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
Lead Sponsor:
NanoSHIFT LLC
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00764361
Start Date
January 1 2009
End Date
August 1 2010
Last Update
April 7 2017
Active Locations (1)
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1
North Florida / South Georgia Veterans Administration Hospital
Gainesville, Florida, United States, 32608