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

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

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.

Study Overview

• Status: Terminated
• Conditions: Surgical Wound Dehiscence
• Intervention / Treatment: Device: PolyHeal 2; Device: Polyheal

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Naharia, Israel
    • Western Galilee Hospital
  • Tel Aviv, Israel
    • Souraski Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PolyHeal 2; Negatively charged 5-micron polystyrene microspheres in Water For Injection	Device: PolyHeal 2; PolyHeal is a sterile medical device; Other Names: PolyHeal; PolyHeal is a sterile medical device
ACTIVE_COMPARATOR: PolyHeal; Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)	Device: Polyheal; PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in; 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?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: MediWound Ltd
• Investigators: Principal Investigator: Alex Berezovsky, MD, Head of Department of Plastic and reconstructive surgery; Principal Investigator: Eyal Gur, MD, Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center; Principal Investigator: Leonid Kogan, MD, Head of Plastic Surgery Department Western Galilee Hospital; Principal Investigator: Yehuda Ulman, Proffesor, Head of Plastic surgery department ,Rambam Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: September 1, 2012
• First Posted (ESTIMATE): September 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Dehiscence
• Other Study ID Numbers: MWPH-2012-08-01