This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.
Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks. Continuation of study device for additional period is based on wound healing progression and under investigator's discretion. Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
PolyHeal is a sterile medical device
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Western Galilee Hospital
Nahariya, Israel
Souraski Medical Center
Tel Aviv, Israel
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
Time frame: 4 weeks
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