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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wounds; Pressure Ulcers; Chronic Wounds; Trauma Wounds; Arterial Ulcers; Diabetic Foot Ulcers (DFUs); Burn Wounds; Venous Leg Ulcers (VLUs)
• Intervention / Treatment: Biological: Amniotic Tissue Allograft

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dr. Bardia Anvar, Doctor of Medicine; Phone Number: (310) 773-6300; Email: anvarb01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATP Treatment Group; Application of Carbonlife ATP per manufacturer's instructions along with standard wound care.	Biological: 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.; Other Names: Amniotic Tissue Graft; Amniotic Tissue Product
No Intervention: Standard Wound Care Group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	Complete wound closure, defined as 100% epithelialization without drainage.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Wound Closure	The time it takes to close the wound.	This is dependent on the time the wound closes, 12 - 20 week estimate.
Wound Area Reduction	Percentage of wound area reduction at 4, 8, and 12 weeks.	12 Weeks
Adverse Events	Tracking the number of adverse events.	12 Weeks
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).	12 Weeks
Visual Analogue Pain Assessment	Using the Visual Analogue Pain Assessment, patients unable to rate their pain numerically, will choose the face that best represents their level of pain. Their response will be scored based on the number (1 through 10) associated with that face. 1 represents no pain, and 10 represents excruciating pain.	12 Weeks

Collaborators and Investigators

• Sponsor: Bardia Anvar
• Collaborators: Carbon Life Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Estimated): November 3, 2025

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: chronic wounds
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Surgical Wound; Diabetic Foot; Burns; Pressure Ulcer
• Other Study ID Numbers: Carbonlife

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The specific IPD that may be included in the reports and publications stemming from this clinical study may include, but is not limited to: age, gender, details on wound etiologies and diagnostics, responses to pain assessments, adverse event reports, comprehensive treatment details, and clinical therapy outcomes. All shared data would be de-identified and used per patient authorization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No