Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds

Официальное название

A Randomized, Outcome Assessor-Blinded Clinical Trial Comparing the Efficacy of Acellular Dermal Matrix (ADM) Hydrogel Versus Alginate Dressings in the Treatment of Chronic Traumatic Wounds

Обзор

The goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (ADM) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks. The main questions it aims to answer are: Does ADM gel reduce the size of chronic wounds more than alginate dressings after 12 weeks? Does ADM gel help wounds heal faster and improve quality of life for patients? Researchers will compare ADM gel to alginate dressings to see if the ADM gel leads to better healing results and fewer complications. Participants will: Be randomly assigned to receive either ADM gel or alginate dressing. Have the treatment applied directly to their cleaned wound. Attend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.

Вмешательства

• Устройство Injectable Acellular dermal matrix hydrogel
  An injectable, sterile acellular dermal matrix (ADM) gel derived from processed biological tissue, designed to promote healing in chronic wounds. The gel is injected directly onto the wound bed following standard debridement and serves as a biocompatible scaffold to support granulation tissue formation, epithelialization, and wound closure. After application, the wound is covered with a standard secondary dressing. Dressing changes are performed every 2 to 3 days or as clinically indicated.
• Устройство Alginate dressing
  A sterile, absorbent alginate wound dressing composed of natural polysaccharide fibers derived from seaweed. Following standard debridement, the alginate dressing is applied directly to the wound bed to manage exudate and maintain a moist wound environment conducive to healing. The dressing is covered with a secondary dressing and changed according to the manufacturer's instructions and clinical protocol.

Первичные конечные точки

• Wound surface area (cm²) at Week 12, adjusted for baseline wound size [Срок оценки: Week 1 and 12]

Вторичные конечные точки (5)

• Time to complete wound healing (100% epithelialization) [Срок оценки: Weekly up to 12 weeks]
• Rate of granulation tissue formation [Срок оценки: Weekly up to 12 weeks]
• Rate of wound epithelialization [Срок оценки: Weekly up to 12 weeks]
• Incidence of complications (infection, necrosis, bleeding) [Срок оценки: Up to 12 weeks]
• Quality of life score at Week 12 [Срок оценки: Weeks 1 and 12]

Критерии участия

Критерии включения

• Chronic trauma wounds persisting ≥3 weeks.
• Wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs.
• Willingness and ability to provide informed consent.
• Wounds without uncontrolled infection

Критерии исключения

• Wounds with exposed bone.
• Current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs.
• Pregnant individuals.
• Significant reduction (≥30%) of wound size during a 2-week run-in phase.
• Concurrent participation in another clinical trial involving drugs.
• Wounds with uncontrolled infection
• Allergy or hypersensitivity to components of ADM gel or alginate

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

Иран · 1 центр

• Alzahra hospital — Isfahan

Идентификаторы

NCT: NCT06978569 · IR.ARI.MUI.REC.1404.054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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