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NCT Number: NCT07223892

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

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.

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Key information

Conditions

Chronic Wounds Arterial Ulcers Burn Wounds Burns Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcers (DFUs) Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Pressure Ulcers Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Surgical Wound Surgical Wounds Trauma Wounds Vascular Diseases Venous Leg Ulcers (VLUs) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Amniotic Tissue Graft, Amniotic Tissue Product

Primary outcomes

  1. Wound Closure

    Time frame: 12 Weeks

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

Secondary outcomes

  1. Duration of Wound Closure

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

    The time it takes to close the wound.

  2. Wound Area Reduction

    Time frame: 12 Weeks

    Percentage of wound area reduction at 4, 8, and 12 weeks.

  3. Adverse Events

    Time frame: 12 Weeks

    Tracking the number of adverse events.

  4. Numerical Pain Assessment

    Time frame: 12 Weeks

    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).

  5. Visual Analogue Pain Assessment

    Time frame: 12 Weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Bardia Anvar, Doctor of Medicine

CONTACT

[email protected]

(310) 773-6300

Sponsors and collaborators

Lead sponsor

Bardia Anvar

Industry

Collaborators

  • Carbon Life Sciences

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 3, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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