A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen

Conditions
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Surgical Wound Dehiscence

Intervention / Treatment
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* Device: PolyHeal 2
* Device: Polyheal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent) Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required. Exclusion Criteria: Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement. Wounds with exposed bones, tendons or ligaments Wounds with exposed orthopedic implants Wounds with exposed breast prostheses Uncontrolled diabetes with HbA1c >11% Subjects with BMI greater than 35kg/m2 Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PolyHeal 2<br>Negatively charged 5-micron polystyrene microspheres in Water For Injection | Device: PolyHeal 2<br>* PolyHeal is a sterile medical device<br>* Other names: PolyHeal is a sterile medical device;|
| Active Comparator: PolyHeal<br>Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM) | Device: Polyheal<br>* PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in<br>* Other names: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase) |  | 4 weeks |