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

NCT ID: NCT07223892

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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chronic wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ATP Treatment Group

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

Group Type EXPERIMENTAL

Amniotic Tissue Allograft

Intervention Type 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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Amniotic Tissue Graft Amniotic Tissue Product

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carbon Life Sciences

INDUSTRY

Sponsor Role collaborator

Bardia Anvar

INDUSTRY

Sponsor Role lead

Responsible Party

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Bardia Anvar

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Dr. Bardia Anvar, Doctor of Medicine

Role: CONTACT

Phone: (310) 773-6300

Email: [email protected]

Other Identifiers

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Carbonlife

Identifier Type: -

Identifier Source: org_study_id