Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds

Официальное название

A Prospective Controlled Trial Evaluating the Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds: A Stratified Analysis by Wound Etiology and Care Setting

Обзор

Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs. These wounds are characterized by delayed healing and are often associated with complex etiologies and prolonged treatment courses. This study aims to evaluate the clinical efficacy and cost-effectiveness of Carbonlife amniotic tissue products (ATPs) compared to standard wound care in the management of chronic wounds. A prospective, controlled clinical trial will be conducted across diverse care settings and patient populations with varying wound etiologies. Participants will be stratified by wound type and treatment environment to enable subgroup analyses. The primary endpoint will assess wound healing outcomes, while secondary endpoints will include quality-of-life measures and healthcare resource utilization. The study is designed to generate high-quality evidence regarding the therapeutic value of ATPs in chronic wound management. Stratified analyses will provide insights into the differential effectiveness of ATPs across clinical contexts. Findings are anticipated to have implications for clinical practice guidelines and healthcare policy, with the goal of improving patient outcomes and optimizing resource allocation in wound care.

Вмешательства

• Биопрепарат Amniotic Tissue Allograft
  The amniotic tissue products will be used to treat patients with chronic wounds to determine if a higher incidence of wound closure or reduction in devitalized tissue occurs.

Первичные конечные точки

• Wound Closure [Срок оценки: 12 Weeks]

Вторичные конечные точки (5)

• Duration of Wound Closure [Срок оценки: This is dependent on the time the wound closes, 12 - 20 week estimate.]
• Wound Area Reduction [Срок оценки: 12 Weeks]
• Adverse Events [Срок оценки: 12 Weeks]
• Numerical Pain Assessment [Срок оценки: 12 Weeks]
• Visual Analogue Pain Assessment [Срок оценки: 12 Weeks]

Критерии участия

Критерии включения

• Facilities and centers with the capacity to follow strict treatment and care guidelines for patients.
• Adults aged 18 years or older.
• Presence of a chronic wound (defined as a wound that has not shown significant improvement in 4 weeks) of any of the following etiologies: Diabetic foot ulcers, Venous leg ulcers, Arterial ulcers, Pressure ulcers, Burns, Trauma, Surgical
• Wound size greater than 1 cm²
• Ability to provide informed consent

Критерии исключения

• Presence of active osteomyelitis
• Untreated malignancy in the wound area
• Known allergy to components of ATPs
• Pregnant or breastfeeding women
• Patients receiving immunosuppressive therapy
• Patients with a life expectancy of less than 12 weeks

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07223892 · Carbonlife

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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