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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT01813305
Eligibility Criteria:
Inclusion Criteria:
* With either gender aged at least 20 years old;
* With a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
* The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner system;
* The target ulcer should show "infection control" at investigator's discretion;
* Subject should be free of any necrosis or infection in soft and bone tissue;
* Subject has signed the written informed consent form
Exclusion Criteria:
* With active osteomyelitis;
* With target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit;
* With poor nutritional status (albumin \< 3g/dl), poor diabetic control (HbA1c \> 12%), anemia (hemoglobin\<10 g/dL), a leukocyte counts \< 1,000/mm3, abnormal liver function (AST, ALT\>3 x upper limit of normal range);
* Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
* Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
* Receiving revascularization surgery performed \<8 weeks before entry in the study;
* With known or suspected hypersensitivity to any ingredients of study product and vehicle;
* With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study;
* Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
* Enrollment in any investigational drug trial within 4 weeks before entering this study;
* With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01813305
Study Brief:
Protocol Section:
NCT01813305