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Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

Primary Purpose

Wounds and Injuries

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Suspension of polystyrene beads (POLYHEAL 1)

Saline (0.9% NaCl)

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Recalcitrant ulcers, Chronic wounds, Venous insufficiency wounds, Ulcers, 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Soroka University Medical CenterRecruiting
Hadassah Ein-Kerem HospitalRecruiting
Western Galilee HospitalRecruiting
Sourasky Medical CenterRecruiting
High Risk Foot Clinic - Maccabi Health ServicesRecruiting
Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Treatment with Polyheal 1

Saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

(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.

Full Information

NCT ID

NCT00552643

First Posted

November 1, 2007

Last Updated

October 27, 2009

Sponsor

Polyheal Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00552643

Brief Title

Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

Official Title

Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Polyheal Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds and Injuries

Keywords

Recalcitrant ulcers, Chronic wounds, Venous insufficiency wounds, Ulcers, 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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Treatment with Polyheal 1

Arm Title

Arm Type

Active Comparator

Arm Description

Saline

Intervention Type

Device

Intervention Name(s)

Suspension of polystyrene beads (POLYHEAL 1)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Saline (0.9% NaCl)

Other Intervention Name(s)

Physiological solution, 0.9% NaCl

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jordan Rubinson

Phone

972-8--9324031

jordanr@polyheal.co.il

First Name & Middle Initial & Last Name or Official Title & Degree

Alla Latovsky, Registered Nurse

Phone

972-522919589

allal@polyheal.co.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gavriel Zeilig, DM

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soroka University Medical Center

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Vigoda, DM

Phone

+972 544542476

davidvi@clalit.org.il

First Name & Middle Initial & Last Name & Degree

David Vigoda, DM

First Name & Middle Initial & Last Name & Degree

Lior Rozenberg, DM

Facility Name

Hadassah Ein-Kerem Hospital

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andr'e Ofek Shlomai, MD

Phone

972-2-6776473

ofek@bgu.ac.il

First Name & Middle Initial & Last Name & Degree

Andr'e Ofek Shlomai, MD

First Name & Middle Initial & Last Name & Degree

Tomer Tzur, MD

First Name & Middle Initial & Last Name & Degree

Livnat Dotan, MD

Facility Name

Western Galilee Hospital

City

Nahariya

ZIP/Postal Code

Post Office Box 21

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leonid Kogan, MD, Ph.D

Phone

+972 507887582

Leonid.Kogan@naharia.health.gov.il

First Name & Middle Initial & Last Name & Degree

Leonid Kogan

First Name & Middle Initial & Last Name & Degree

Haikin Natalia, MD

Facility Name

Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoav Barnea, MD

Phone

(972)-52-466-523

barneay@netvision.net.il

First Name & Middle Initial & Last Name & Degree

Jerry Weiss, MD

First Name & Middle Initial & Last Name & Degree

Yoav Barnea, MD

First Name & Middle Initial & Last Name & Degree

Udi Arad, MD

First Name & Middle Initial & Last Name & Degree

Amir Inbal, MD

Facility Name

High Risk Foot Clinic - Maccabi Health Services

City

Tel Aviv

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eran Tamir, MD

Phone

972-546-247-009

eranetta@012.net.il

First Name & Middle Initial & Last Name & Degree

Eran Tanir, MD

Facility Name

Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

52620

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eli Regev, MD

Phone

+972 544 494 554

erplast@gmail.com

First Name & Middle Initial & Last Name & Degree

Gavriel Zeilig, MD

First Name & Middle Initial & Last Name & Degree

Eli Regev, MD

First Name & Middle Initial & Last Name & Degree

Evgeni Gaidakov, MD

12. IPD Sharing Statement

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Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

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