Lower Extremity Chronic Ulcers in DiabeticsNCT07219004
Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
A study testing amniotic membrane in people with Lower Extremity Chronic Ulcers in Diabetics and Diabetic Foot Ulcer (DFU), run by Tides Medical at 5 sites in United States.
Trial summary
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
- What is being tested?
- amniotic membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Mar 2023to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects will be eligible to participate in the study if all the following conditions exist:
- Potential subjects are required to meet all the following criteria for enrollment into the study.
- Subjects must be at least 18 years of age or older,
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At entry subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the MolecuLight Imaging HCT/P 361 .
- The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
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- The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- The target ulcer must be full thickness without exposed bone.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
- The subject must consent to using the prescribed off-loading method for the duration of the study.
- The subject must agree to attend the weekly study visits required by the protocol.
- The subject must be willing and able to participate in the informed consent process.
Who cannot join
- Subjects will be excluded from participation in the study if any of the following conditions exist:
- A subject known to have a life expectancy of < 6 months is excluded.
- The subject is excluded if the target ulcer is not secondary to diabetes.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
- If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
- A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
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- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
- A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
- If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit he/she is excluded.
- The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the subject received SOC.
- A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
- Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
- A potential subject with end stage renal disease requiring dialysis is excluded.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
- A subject who in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
- A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Serena Group Austin Research Center
Austin, Texas, 78701
Serena Group Reseach Center
Buffalo, New York, 14203
El Campo Memorial Advanced Wound Care Clinic
El Campo, Texas, 77437
Serena Group
Monroeville, Pennsylvania, 15146
Three Rivers Wound and Hyperbaric Center
North Port, Florida, 34289
About this study
Official title: A Prospective Multi-ceter Clinical Trail. Evaluating the Efficacy of Tri-layer Amnion/Chorion/Amnion (Artacent-AC) and Standard of Care in the Treatment of Chronic Lower Extremity Diabetic Ulcers.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
Read the detailed description
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal > 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.
- Being tested
- amniotic membrane
- Keywords
- Diabetic Foot Ulcers, Chronic foot ulcers, Plantar Ulcers, Lower Extremity Ulcers, Amniotic Tissues, HCT/P, 361 products, Q4190
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic membraneOther
Also called Chorion, Q4190, Amnion
The intervention is a trial-layer human amnion/chorion/amnion composite graft
| Study group | Role | What they receive |
|---|---|---|
| Artacent-AC | Experimental | Artacent AC®is a HCT/P regulated solely as a "361 Product" and meets all criteria in 21 CFR 1271.10(a). The amnion and chorion layers are harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean the amniotic and chorion membranes. A Tri-Layered Amniotic Membrane (TLAM) is then formed by adding two outer layers of amnion with the stromal sides facing outward, separated by a middle chorion layer. TLAM is dried and cut into various sizes, packaged, and terminally sterilized.
Artacent AC, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers as a wound cover. Receives: Other: amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound closure by percent of complete epithelialization
complete wound closure measured by 100% epithelialization
Measured: 12 weeks
Secondary outcomes (1)
Percent area reduction
Precent of the wound which has been re-epithelialized
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 posted21 Oct 2025
- Study start3 Mar 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Chronic Ulcers in DiabeticsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tides Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, Serena Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219004
- Sponsor's protocol ID
- POC-AC
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2025
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Propritary study design
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-ceter Clinical Trail. Evaluating the Efficacy of Tri-layer Amnion/Chorion/Amnion (Artacent-AC) and Standard of Care in the Treatment of Chronic Lower Extremity Diabetic Ulcers.
- ClinicalTrials.gov ID
- NCT07219004
- Acronym / sponsor ID
- POC-AC
- Keywords
- Diabetic Foot Ulcers, Chronic foot ulcers, Plantar Ulcers, Lower Extremity Ulcers, Amniotic Tissues, HCT/P, 361 products, Q4190
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tides MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 21 Oct 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.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
Detailed description
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal > 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artacent-AC | Experimental | Other: amniotic membraneArtacent AC®is a HCT/P regulated solely as a "361 Product" and meets all criteria in 21 CFR 1271.10(a). The amnion and chorion layers are harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean the amniotic and chorion membranes. A Tri-Layered Amniotic Membrane (TLAM) is then formed by adding two outer layers of amnion with the stromal sides facing outward, separated by a middle chorion layer. TLAM is dried and cut into various sizes, packaged, and terminally sterilized. Artacent AC, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers as a wound cover. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects will be eligible to participate in the study if all the following conditions exist:
- Potential subjects are required to meet all the following criteria for enrollment into the study.
- Subjects must be at least 18 years of age or older,
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At entry subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the MolecuLight Imaging HCT/P 361 .
Key exclusion criteria (17 listed)
- Subjects will be excluded from participation in the study if any of the following conditions exist:
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 membraneAlso: Chorion, Q4190, AmnionThe intervention is a trial-layer human amnion/chorion/amnion composite graft | Other | Artacent-AC |
Primary outcome
Rate of wound closure by percent of complete epithelialization
Time frame: 12 weeks
complete wound closure measured by 100% epithelialization
1 secondary outcome
Percent area reduction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No. Propritary study design
Related trials for Lower Extremity Chronic Ulcers in Diabetics
Enrolling by invitation
Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds
Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers
Recruiting
Additional Hyperbaric Oxygen After Lower Extremity Amputation
Diabetes Mellitus, Claudication, Intermittent
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. This study is not recruiting at the moment.
Thomas Serena, MD principal investigator
Serena Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniotic membrane in people with Lower Extremity Chronic Ulcers in Diabetics and Diabetic Foot Ulcer (DFU), run by Tides Medical at 5 sites in United States.
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 18 inclusion and 17 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: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of wound closure by percent of complete epithelialization (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 21 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.