Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 9:21 AM
Study NCT ID:
NCT07223892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Sponsor:
Bardia Anvar
Organization:
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: