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Sponsored by: |
Polyheal Ltd. |
Information provided by: | Polyheal Ltd. |
ClinicalTrials.gov Identifier: | NCT00552643 |
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 | Intervention |
Wounds and Injuries |
Device: Suspension of polystyrene beads (POLYHEAL 1) Device: Saline (0.9% NaCl) |
MedlinePlus related topics: | Injuries Wounds |
ChemIDplus related topics: | Sodium chloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds |
Estimated Enrollment: | 60 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Treatment with Polyheal 1
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Device: Suspension of polystyrene beads (POLYHEAL 1)
Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle
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2: Active Comparator
Saline
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Device: Saline (0.9% NaCl)
Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dov Reichman, Ph.D.. | 972-8--9324013 | dov@polyheal.co.il |
Contact: Alla Latovsky, Registered Nurse | 972-522919589 | allal@polyheal.co.il |
Israel | |||||
Soroka University Medical Center | Recruiting | ||||
Beer Sheva, Israel, 84101 | |||||
Contact: David Vigoda, DM +972 544542476 davidvi@clalit.org.il | |||||
Sub-Investigator: David Vigoda, DM | |||||
Principal Investigator: Lior Rozenberg, DM | |||||
Sheba Medical Center | Recruiting | ||||
Tel Hashomer, Israel, 52620 | |||||
Contact: Eli Regev, MD +972 544 494 554 erplast@gmail.com | |||||
Principal Investigator: Gavriel Zeilig, MD | |||||
Sub-Investigator: Eli Regev, MD | |||||
Western Galilee Hospital | Recruiting | ||||
Nahariya, Israel, Post Office Box 21 | |||||
Contact: Leonid Kogan, MD, Ph.D +972 507887582 Leonid.Kogan@naharia.health.gov.il | |||||
Sourasky Medical Center | Not yet recruiting | ||||
Tel Aviv, Israel, 64239 | |||||
Contact: Yoav Barnea, MD (972)-52-466-523 barneay@netvision.net.il | |||||
Principal Investigator: Jerry Weiss, MD | |||||
Sub-Investigator: Yoav Barnea, MD |
Polyheal Ltd. |
Principal Investigator: | Gavriel Zeilig, DM | Sheba Medical Center, Tel Hashomer, Israel |
Responsible Party: | Polyheal Ltd ( Dov Richman, CEO ) |
Study ID Numbers: | PH1-07-01 |
First Received: | November 1, 2007 |
Last Updated: | August 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00552643 |
Health Authority: | Israel: Ethics Commission |
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