Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amniotic Tissue Allograft.
- Who it may be relevant to
- Registry conditions: Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Wound Closure [Time frame: 12 Weeks]
Secondary outcome measures (5)
- Duration of Wound Closure [Time frame: This is dependent on the time the wound closes, 12 - 20 week estimate.]
- Wound Area Reduction [Time frame: 12 Weeks]
- Adverse Events [Time frame: 12 Weeks]
- Numerical Pain Assessment [Time frame: 12 Weeks]
- Visual Analogue Pain Assessment [Time frame: 12 Weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07223892 · Carbonlife