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

NCT ID: NCT01679678

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-08-31

Brief Summary

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

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.

Conditions

Surgical Wound Dehiscence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PolyHeal 2

Negatively charged 5-micron polystyrene microspheres in Water For Injection

Group Type: EXPERIMENTAL

PolyHeal 2

Intervention Type: DEVICE

PolyHeal is a sterile medical device

PolyHeal

Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)

Group Type: ACTIVE_COMPARATOR

Polyheal

Intervention Type: DEVICE

PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in

Interventions

PolyHeal 2

PolyHeal is a sterile medical device

Intervention Type: DEVICE

Polyheal

PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in

Intervention Type: DEVICE

Other Intervention Names

PolyHeal; PolyHeal is a sterile medical device; PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediWound Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Berezovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Plastic and reconstructive surgery

Eyal Gur, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center

Leonid Kogan, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Plastic Surgery Department Western Galilee Hospital

Yehuda Ulman, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Head of Plastic surgery department ,Rambam Medical Center

Locations

Soroka Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Western Galilee Hospital

Nahariya, , Israel

Souraski Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

MWPH-2012-08-01

Identifier Type: -

Identifier Source: org_study_id