Chronic WoundsPhase 3NCT07223892
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
A Phase 3 study testing Amniotic Tissue Allograft in people with Chronic Wounds and Venous Leg Ulcers (VLUs), run by Bardia Anvar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs)
- What is being tested?
- Amniotic Tissue Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Amniotic Tissue Allograft
- Keywords
- chronic wounds
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Burns, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Tissue AllograftBiological
Also called Amniotic Tissue Graft, Amniotic Tissue Product
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.
| Study group | Role | What they receive |
|---|---|---|
| ATP Treatment Group | Experimental | Application of Carbonlife ATP per manufacturer's instructions along with standard wound care. Receives: Biological: Amniotic Tissue Allograft |
| Standard Wound Care Group | No intervention | Patients will not received Amnionic Tissue Product to treat chronic wounds. Participants will receive: * Wound debridement as needed * Dressing selection based on wound characteristics * Compression therapy for venous ulcers (if indicated) * Offloading for pressure ulcers (if indicated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Complete wound closure, defined as 100% epithelialization without drainage.
Measured: 12 Weeks
Secondary outcomes (5)
Duration of Wound Closure
The time it takes to close the wound.
Measured: This is dependent on the time the wound closes, 12 - 20 week estimate.
Wound Area Reduction
Percentage of wound area reduction at 4, 8, and 12 weeks.
Measured: 12 Weeks
Adverse Events
Tracking the number of adverse events.
Measured: 12 Weeks
Numerical Pain Assessment
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).
Measured: 12 Weeks
Visual Analogue Pain Assessment
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bardia Anvar
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carbon Life Sciences
- Responsible party
- Sponsor-investigator, Bardia Anvar, Carbon Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223892
- Sponsor's protocol ID
- Carbonlife
- Status last verified
- Nov 2025
- First submitted
- 23 Oct 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The specific IPD that may be included in the reports and publications stemming from this clinical study may include, but is not limited to: age, gender, details on wound etiologies and diagnostics, responses to pain assessments, adverse event reports, comprehensive treatment details, and clinical therapy outcomes. All shared data would be de-identified and used per patient authorization.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07223892
- Acronym / sponsor ID
- Carbonlife
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers, Pressure Ulcers, Burn Wounds
- Keywords
- chronic wounds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bardia AnvarIndustry (pharma, biotech, devices)
- Collaborators
- Carbon Life Sciences
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATP Treatment Group | Experimental | Biological: Amniotic Tissue AllograftApplication of Carbonlife ATP per manufacturer's instructions along with standard wound care. |
| Standard Wound Care Group | No intervention | –Patients will not received Amnionic Tissue Product to treat chronic wounds. Participants will receive: * Wound debridement as needed * Dressing selection based on wound characteristics * Compression therapy for venous ulcers (if indicated) * Offloading for pressure ulcers (if indicated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Presence of active osteomyelitis
- Untreated malignancy in the wound area
- Known allergy to components of ATPs
- Pregnant or breastfeeding women
- Patients receiving immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Tissue AllograftAlso: Amniotic Tissue Graft, Amniotic Tissue ProductThe 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. | Biological | ATP Treatment Group |
Primary outcome
Wound Closure
Time frame: 12 Weeks
Complete wound closure, defined as 100% epithelialization without drainage.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Yes. The specific IPD that may be included in the reports and publications stemming from this clinical study may include, but is not limited to: age, gender, details on wound etiologies and diagnostics, responses to pain assessments, adverse event reports, comprehensive treatment details, and clinical therapy outcomes. All shared data would be de-identified and used per patient authorization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amniotic Tissue Allograft in people with Chronic Wounds and Venous Leg Ulcers (VLUs), run by Bardia Anvar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Bardia Anvar, Doctor of Medicine ((310) 773-6300, anvarb01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.