Trials / Not Yet Recruiting
Not Yet RecruitingNCT07223892
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Bardia Anvar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2028-01-01
- Completion
- 2028-03-01
- First posted
- 2025-11-03
- Last updated
- 2025-11-06
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07223892. Inclusion in this directory is not an endorsement.