. 2020 May 4;6(5):e03929. doi: 10.1016/j.heliyon.2020.e03929

Table 1.

Inclusion and exclusion criteria for patient selection.

Inclusion Criteria	Exclusion 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 cmˆ2 and 20 cmˆ2, 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, HbA1c) • Approved, informed, signed consent to be obtained from each patient.	• 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∗ 10ˆ9/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.

Inclusion Criteria

Exclusion 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 cmˆ2 and 20 cmˆ2, 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, HbA1c)
•
Approved, informed, signed consent to be obtained from each patient.

•
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∗ 10ˆ9/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.