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

Bardia Anvar

Status and phase: Not yet enrolling; Phase 3

Conditions: Venous Leg Ulcers (VLUs); Burn Wounds; Surgical Wounds; Trauma Wounds; Arterial Ulcers; Chronic Wounds; Diabetic Foot Ulcers (DFUs); Pressure Ulcers

Treatments: Biological: Amniotic Tissue Allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223892

Carbonlife

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

ATP Treatment Group

Experimental group

Description:

Application of Carbonlife ATP per manufacturer's instructions along with standard wound care.

Treatment:

Biological: Amniotic Tissue Allograft

Standard Wound Care Group

No Intervention group

Description:

Patients will not received Amnionic Tissue Product to treat chronic wounds. Participants will receive: * Wound debridement as needed * Dressing selection based on wound characteristics * Compression therapy for venous ulcers (if indicated) * Offloading for pressure ulcers (if indicated)