Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

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.

Study Overview

• Status: Unknown
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Suspension of polystyrene beads (POLYHEAL 1); Device: Saline (0.9% NaCl)

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Rubinson; Phone Number: 972-8--9324031; Email: jordanr@polyheal.co.il
• Study Contact Backup: Name: Alla Latovsky, Registered Nurse; Phone Number: 972-522919589; Email: allal@polyheal.co.il

Study Locations

• Israel
  • Beer Sheva, Israel, 84101
    • Recruiting
    • Soroka University Medical Center
    • Contact: David Vigoda, DM; Phone Number: +972 544542476; Email: davidvi@clalit.org.il
    • Sub-Investigator: David Vigoda, DM
    • Principal Investigator: Lior Rozenberg, DM
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Ein-Kerem Hospital
    • Contact: Andr'e Ofek Shlomai, MD; Phone Number: 972-2-6776473; Email: ofek@bgu.ac.il
    • Principal Investigator: Andr'e Ofek Shlomai, MD
    • Sub-Investigator: Tomer Tzur, MD
    • Sub-Investigator: Livnat Dotan, MD
  • Nahariya, Israel, Post Office Box 21
    • Recruiting
    • Western Galilee Hospital
    • Contact: Leonid Kogan, MD, Ph.D; Phone Number: +972 507887582; Email: Leonid.Kogan@naharia.health.gov.il
    • Principal Investigator: Leonid Kogan
    • Sub-Investigator: Haikin Natalia, MD
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Sourasky Medical Center
    • Contact: Yoav Barnea, MD; Phone Number: (972)-52-466-523; Email: barneay@netvision.net.il
    • Principal Investigator: Jerry Weiss, MD
    • Sub-Investigator: Yoav Barnea, MD
    • Sub-Investigator: Udi Arad, MD
    • Sub-Investigator: Amir Inbal, MD
  • Tel Aviv, Israel
    • Recruiting
    • High Risk Foot Clinic - Maccabi Health Services
    • Contact: Eran Tamir, MD; Phone Number: 972-546-247-009; Email: eranetta@012.net.il
    • Principal Investigator: Eran Tanir, MD
  • Tel Hashomer, Israel, 52620
    • Recruiting
    • Sheba Medical Center
    • Contact: Eli Regev, MD; Phone Number: +972 544 494 554; Email: erplast@gmail.com
    • Principal Investigator: Gavriel Zeilig, MD
    • Sub-Investigator: Eli Regev, MD
    • Sub-Investigator: Evgeni Gaidakov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
(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.	12 weeks

Collaborators and Investigators

• Sponsor: Polyheal Ltd.
• Investigators: Principal Investigator: Gavriel Zeilig, DM, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: November 1, 2007
• First Submitted That Met QC Criteria: November 1, 2007
• First Posted (Estimate): November 2, 2007

Study Record Updates

• Last Update Posted (Estimate): October 28, 2009
• Last Update Submitted That Met QC Criteria: October 27, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Wound healing; Ulcers; Chronic wounds; Wound care; Recalcitrant ulcers; Venous insufficiency wounds; Exposed bones; Exposed Tendons; Granulation tissue; Polyheal 1; 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
• Other Study ID Numbers: PH1-07-01