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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

This study has been terminated.
(Business considerations)
Information provided by (Responsible Party):
MediWound Ltd Identifier:
First received: August 20, 2012
Last updated: March 29, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Surgical Wound Dehiscence
Device: PolyHeal 2
Device: Polyheal
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by MediWound Ltd:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01679678

Soroka Medical Center
Beer Sheva, Israel
Rambam Medical Center
Haifa, Israel
Western Galilee Hospital
Naharia, Israel
Souraski Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
MediWound Ltd
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
  More Information

Responsible Party: MediWound Ltd Identifier: NCT01679678     History of Changes
Other Study ID Numbers: MWPH-2012-08-01
Study First Received: August 20, 2012
Last Updated: March 29, 2016

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound Dehiscence
Postoperative Complications
Pathologic Processes processed this record on May 23, 2017