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.
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
Presence of active osteomyelitis
Untreated malignancy in the wound area
Known allergy to components of ATPs
Pregnant or breastfeeding women
Parallel
Amniotic Tissue Allograft
Biological/VaccineThe 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.
Wound Closure
Complete wound closure, defined as 100% epithelialization without drainage.
Duration of Wound Closure
The time it takes to close the wound.
Wound Area Reduction
Percentage of wound area reduction at 4, 8, and 12 weeks.
Adverse Events
Tracking the number of adverse events.
Numerical Pain Assessment
Using the Numerical Pain Assessment, patients will rate their level of pain on a scale from 1 to 10 (1 being no pain and 10 being excruciating pain).
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