The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Whole blood clot (WBC) gel
Emek Medical Center
Afula, Israel
Percent of Reduction in Wound Size Over 12 Weeks
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Time frame: 4, 8, and 12 weeks
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Time frame: 12 weeks
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Time frame: 18 and 24 weeks
Percent of Reduction in Wound Size Over 18 and 24 Weeks.
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage for wound treated beyond 12 weeks, per the investigator's decision
Time frame: 18 and 24 weeks
The change in wound pain by 12 weeks
Pain assessment would be done by using the Numeric Rating Scale (NRS). Subject chooses a number on a 1 to 10 scale that best describes his ulcer pain, while 0 represents "No Pain" and 10- " Worst Pain Imaginable "test, a scale between .
Time frame: 12 weeks
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