Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552643
Recruitment Status : Unknown
Verified October 2009 by Polyheal Ltd..
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : October 28, 2009
Information provided by:
Polyheal Ltd.

Brief Summary:
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Device: Suspension of polystyrene beads (POLYHEAL 1) Device: Saline (0.9% NaCl) Not Applicable

Detailed Description:

Chronic ulcers affect millions of people, and are a growing clinical problem seen most frequently in the elderly. Non-healing or slow healing wounds represent a major health burden and drain on resources, contributing to substantial disability, morbidity, and cost. Wound healing involves a well-orchestrated, complex process leading to repair of injured tissues. Basic principles of good wound care involve removal of necrotic tissue by mechanical, surgical or enzymatic debridement, wound bed preparation, and treatment of infection. In general, wounds that are being appropriately managed show measurable progress within 2-4 weeks. However despite delivering good wound care that includes providing the right dressings, nutritional support, topical care, and offering top-of-the-line support surfaces, wounds often become stagnated. Wounds refractory to treatment for 2-4 weeks are dubbed recalcitrant. Such wounds need sometime some stimuli to start the healing cascade. Polyheal-1, is thought do be potentially useful in triggering the healing process and can be particularly beneficial in stimulating the granulation process in chronic wounds of different etiologies e.g. venous, diabetic wounds, decubitus ulcers and post trauma/surgery complicated wounds. For instance exposed bones and tendons that are particularly difficult to be treated, were previously demonstrated to benefit from stimulation of granulation coverage by application of Polyheal 1.

In this protocol we intent to perform comparative study aimed at comparing performance of Polyheal I to Saline in treatment of recalcitrant wounds of different etiology such as venous and various post-operative wounds including cases were the exposed bone needs granulation coverage. Furthermore, patients with post- operative surgical complications such as sternum or partial foot amputation in diabetic patients will also be a subject of present investigation. Polyheal 1 will be compared to saline as this is the most commonly used treatment intended at keeping the wound moist and enabling progress of granulation and epithelization.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
Study Start Date : May 2008
Estimated Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Treatment with Polyheal 1
Device: Suspension of polystyrene beads (POLYHEAL 1)
Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle

Active Comparator: 2
Device: Saline (0.9% NaCl)
Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle
Other Names:
  • Physiological solution
  • 0.9% NaCl

Primary Outcome Measures :
  1. Primary Outcome Measures:The primary endpoint will be achievement of at least 75% light red granulation tissue, (grade 7 or 8 on the granulometer), [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. (1) time to complete wound closure measured in weeks, (2) achievement of complete wound closure, measured by number of patients out of total. (3) time to full bone coverage by granulation tissue measured in weeks. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient is 18 years of age and older.
  • The patient has at least one recalcitrant wound (venous insufficiency, post- operative and post-traumatic chronic wounds with different etiology including those with open wounds) refractive to healing at least 4 weeks prior to treatment
  • Patients defined as grade 4 or below on the granulometer including wounds with exposed bone or tendon.
  • Patients will be eligible to participate in the study if their target lesion area of the edges is larger than 15cm2 and smaller than 200 cm2 at baseline in the group A of wounds caused by venous insufficiency or larger than 2cm2 and smaller than 200 cm2 at baseline in the group B of post-operative and post- traumatic chronic wounds with exposed bone, tendon and/or ligaments.
  • The patient is expected to be available for the 12 weeks study.

Exclusion Criteria:

  • Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable.
  • Wound has necrotic tissue which covers more than 50% of the wound area.
  • Neuropathic wounds of diabetic origin.
  • Roentgenic (X-ray) evidence of osteomyelitis in target wound in case that the bone is detectable by insertion of wire.
  • Diabetic patients with HbA1c >11%
  • Presence of a systemic infection or significant local infection such as cellulites, purulent drainage, gangrene, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
  • Previous history of any illness or condition that may impair wound healing, immune deficiency or connective tissue disease (e.g., SLE, AIDS), neurological disease (e.g., multiple sclerosis), dialysis due to renal disease and active hepatic disease.
  • Patient is receiving, or has received within one month prior to Visit 1 any treatment known to impair wound healing, including but not limited to: corticosteroids, immuno- suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
  • Patient has a history of alcohol or drug abuse within the last two years.
  • Presence or suspicion of any malignancy.
  • Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
  • Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
  • Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552643

Contact: Jordan Rubinson 972-8--9324031
Contact: Alla Latovsky, Registered Nurse 972-522919589

Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: David Vigoda, DM    +972 544542476   
Sub-Investigator: David Vigoda, DM         
Principal Investigator: Lior Rozenberg, DM         
Hadassah Ein-Kerem Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Andr'e Ofek Shlomai, MD    972-2-6776473   
Principal Investigator: Andr'e Ofek Shlomai, MD         
Sub-Investigator: Tomer Tzur, MD         
Sub-Investigator: Livnat Dotan, MD         
Western Galilee Hospital Recruiting
Nahariya, Israel, Post Office Box 21
Contact: Leonid Kogan, MD, Ph.D    +972 507887582   
Principal Investigator: Leonid Kogan         
Sub-Investigator: Haikin Natalia, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Yoav Barnea, MD    (972)-52-466-523   
Principal Investigator: Jerry Weiss, MD         
Sub-Investigator: Yoav Barnea, MD         
Sub-Investigator: Udi Arad, MD         
Sub-Investigator: Amir Inbal, MD         
High Risk Foot Clinic - Maccabi Health Services Recruiting
Tel Aviv, Israel
Contact: Eran Tamir, MD    972-546-247-009   
Principal Investigator: Eran Tanir, MD         
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52620
Contact: Eli Regev, MD    +972 544 494 554   
Principal Investigator: Gavriel Zeilig, MD         
Sub-Investigator: Eli Regev, MD         
Sub-Investigator: Evgeni Gaidakov, MD         
Sponsors and Collaborators
Polyheal Ltd.
Principal Investigator: Gavriel Zeilig, DM Sheba Medical Center Tel-Hashomer, Israel

Responsible Party: Jordan Rubinson, CEO, Polyheal Ltd Identifier: NCT00552643     History of Changes
Other Study ID Numbers: PH1-07-01
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: October 28, 2009
Last Verified: October 2009

Keywords provided by Polyheal Ltd.:
Recalcitrant ulcers
Chronic wounds
Venous insufficiency wounds
Exposed bones
Exposed Tendons
Granulation tissue
Polyheal 1
Wound care
Wound healing
Diabetic wounds healing
Post trauma
Post surgery complication
Recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and tendon.

Additional relevant MeSH terms:
Wounds and Injuries