Arterial Ulcers, Burn Wounds, Chronic Wounds, Diabetic Foot Ulcers (DFUs), Pressure Ulcers, Surgical Wounds, Trauma Wounds, Venous Leg Ulcers (VLUs)
Conditions
Keywords
chronic wounds
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.
Interventions
BIOLOGICALAmniotic 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
Carbon Life Sciences
Bardia Anvar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | 12 Weeks | Complete wound closure, defined as 100% epithelialization without drainage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Wound Closure | This is dependent on the time the wound closes, 12 - 20 week estimate. | The time it takes to close the wound. |
| Wound Area Reduction | 12 Weeks | Percentage of wound area reduction at 4, 8, and 12 weeks. |
| Adverse Events | 12 Weeks | Tracking the number of adverse events. |
| Numerical Pain Assessment | 12 Weeks | Using the Numerical Pain Assessment, patients will rate their level of pain on a scale from 1 to 10 (1 being no pain and 10 being excruciating pain). |
| Visual Analogue Pain Assessment | 12 Weeks | Using the Visual Analogue Pain Assessment, patients unable to rate their pain numerically, will choose the face that best represents their level of pain. Their response will be scored based on the number (1 through 10) associated with that face. 1 represents no pain, and 10 represents excruciating pain. |
Contacts
Primary ContactDr. Bardia Anvar, Doctor of Medicine
Outcome results
None listed