Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

NCT ID: NCT00552643

Last Updated: 2009-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31

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.

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.

Conditions

Wounds and Injuries

Study Design

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

Study Groups

1

Treatment with Polyheal 1

Group Type: EXPERIMENTAL

Suspension of polystyrene beads (POLYHEAL 1)

Intervention Type: DEVICE

Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle

2

Saline

Group Type: ACTIVE_COMPARATOR

Saline (0.9% NaCl)

Intervention Type: DEVICE

Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle

Interventions

Suspension of polystyrene beads (POLYHEAL 1)

Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle

Intervention Type: DEVICE

Saline (0.9% NaCl)

Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle

Intervention Type: DEVICE

Other Intervention Names

Physiological solution; 0.9% NaCl

Eligibility Criteria

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.

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

Sponsors

Polyheal Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Polyheal Ltd

Principal Investigators

Gavriel Zeilig, DM

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Soroka University Medical Center

Beersheba, , Israel

Site Status: RECRUITING

Hadassah Ein-Kerem Hospital

Jerusalem, , Israel

Site Status: RECRUITING

Western Galilee Hospital

Nahariya, , Israel

Site Status: RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

High Risk Foot Clinic - Maccabi Health Services

Tel Aviv, , Israel

Site Status: RECRUITING

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Jordan Rubinson

Role: CONTACT

jordanr@polyheal.co.il

972-8--9324031

Alla Latovsky, Registered Nurse

Role: CONTACT

allal@polyheal.co.il

972-522919589

Facility Contacts

David Vigoda, DM

Role: primary

davidvi@clalit.org.il

+972 544542476

Andr'e Ofek Shlomai, MD

Role: primary

ofek@bgu.ac.il

972-2-6776473

Leonid Kogan, MD, Ph.D

Role: primary

Leonid.Kogan@naharia.health.gov.il

+972 507887582

Yoav Barnea, MD

Role: primary

barneay@netvision.net.il

(972)-52-466-523

Eran Tamir, MD

Role: primary

eranetta@012.net.il

972-546-247-009

Eli Regev, MD

Role: primary

erplast@gmail.com

+972 544 494 554

Other Identifiers

PH1-07-01

Identifier Type: -

Identifier Source: org_study_id