Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT00764361
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00764361
Study Brief:
Protocol Section:
NCT00764361