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

NCT07223892 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: Carbonlife
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

chronic wounds

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  Complete wound closure, defined as 100% epithelialization without drainage.

  12 Weeks

Secondary Outcomes (5)

• Duration of Wound Closure

  This is dependent on the time the wound closes, 12 - 20 week estimate.

• Wound Area Reduction

  12 Weeks

• Adverse Events

  12 Weeks

• Numerical Pain Assessment

  12 Weeks

• Visual Analogue Pain Assessment

  12 Weeks

Study Arms (2)

ATP Treatment Group

EXPERIMENTAL

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

Biological: Amniotic Tissue Allograft

Standard Wound Care Group

NO INTERVENTION

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)

Interventions

Amniotic Tissue Allograft BIOLOGICAL

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.

Also known as: Amniotic Tissue Graft, Amniotic Tissue Product

ATP Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bardia Anvar: lead
• Carbon Life Sciences: collaborator

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer; Burns; Surgical Wound

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries

Central Study Contacts

Dr. Bardia Anvar, Doctor of Medicine

CONTACT

(310) 773-6300; anvarb01@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: November 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share