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

NCT07223892 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-11-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Carbon Life Sciences

    collaborator INDUSTRY

  • Bardia Anvar

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-31
Completion
2028-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223892 on ClinicalTrials.gov