Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

NCT00552643 | Unknown

• 1 other identifier: PH1-07-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

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.

Outcome Measures

Primary Outcomes (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),

  12 weeks

Secondary Outcomes (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.

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Treatment with Polyheal 1

Device: Suspension of polystyrene beads (POLYHEAL 1)

2

ACTIVE COMPARATOR

Saline

Device: Saline (0.9% NaCl)

Interventions

Suspension of polystyrene beads (POLYHEAL 1) DEVICE

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

1

Saline (0.9% NaCl) DEVICE

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

Also known as: Physiological solution, 0.9% NaCl

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polyheal Ltd.: lead

Study Sites (6)

Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

Hadassah Ein-Kerem Hospital

Jerusalem, 91120, Israel

RECRUITING

Western Galilee Hospital

Nahariya, Post Office Box 21, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

High Risk Foot Clinic - Maccabi Health Services

Tel Aviv, Israel

RECRUITING

Sheba Medical Center

Tel Litwinsky, 52620, Israel

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavriel Zeilig, DM

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Rubinson

CONTACT

972-8--9324031; jordanr@polyheal.co.il

Alla Latovsky, Registered Nurse

CONTACT

972-522919589; allal@polyheal.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: October 28, 2009

Record last verified: 2009-10

Locations

IL (6)