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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT02989961
Eligibility Criteria:
Inclusion Criteria:
* People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
* Hb1c of less than 13 %.
* Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length\*width) measurement between 0.5 cm\^2 and 20 cm\^2, inclusive.
* Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
* Wagner Grade II or III ulcer.
* The protocol requires that post-debridement, the ulcer would be free of necrotic debris, foreign bodies, or sinus tracts.
* Non invasive vascular testing Ankle Brachial Index (ABI).
* Physical examination (Including a Semmes-Weinstein monofilament test for neuropathy).
* Blood tests to be obtained (CBC, Hb1c)
* Approved, informed, signed consent to be obtained from each patient.
Exclusion Criteria:
* Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
* Ulcer area decreased \> 50% during the seven-day screening period.
* Ulcer is due to a non-diabetic etiology.
* Evidence of gangrene in ulcer or on any part of the foot.
* Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
* Patient has received growth factor therapy within 7 days of randomization.
* Screening platelets count \< 100\* 10\^9/L.
* Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder.
* History of peripheral vascular repair within 30 days of randomization.
* Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer.
* History of alcohol or drug abuse within the last year prior to randomization.
* Patient has inadequate venous access for blood withdraw.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02989961
Study Brief:
Protocol Section:
NCT02989961