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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT01418456
Eligibility Criteria:
Inclusion Criteria:
* Patients will be eligible for study participation if he or she meets the following criteria
* Male or female age 18-85 years inclusive
* Have been diagnosed with Type 1 or Type 2 diabetes
* Must be able to speak and understand English and be able to provide meaningful written informed consent .
* If female, is nonpregnant (negative pregnancy tests at the baseline visit) and nonlactating.
* If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\]) or practising one of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
* Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline visit.
* Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline visit).
* Intrauterine device
* Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
* Present with one or more diabetic foot ulcers on or below the malleoli with no clinical signs of infection (using the Infectious Disease Society of America/International Working Group on the Diabetic Foot Guidelines).
Exclusion Criteria:
* Female subjects who are pregnant or breast feeding
* Any known intolerance or allergy or reported adverse reaction to any antibiotics
* Known osteomyelitis
* Patients with foot ulcers with clinical signs of infection
* Ulceration caused primarily by a disease other than diabetes.
* Any other serious disease likely to compromise the outcome of the trial.
* Evidence of critical renal disease (creatinine \>300µmol/L)
* Patients taking immunosuppressants or any other preparation which may interfere with healing.
* Participation in another clinical trial in the previous 28 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01418456
Study Brief:
Protocol Section:
NCT01418456