Wounds and Injuries Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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