Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)
NCT ID: NCT04457752
Last Updated: 2022-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
124 participants
INTERVENTIONAL
2020-09-01
2023-03-31
Brief Summary
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Detailed Description
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In recent years, several clinical trials have demonstrated that products derived from human placental membranes promote the healing of DFUs5. Research has confirmed that growth factors present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6. All these factors are highly desirable properties in the healing of chronic DFUs.
A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA) potentially can increase the delivery of growth factors due to its double layer of amniotic membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at 12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy of DLAM in DFUs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Atracent®, 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.
TREATMENT
NONE
Study Groups
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Dual Layer Amniotic Membrane (DLAM) + SOC
DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).
Dual Layer Amniotic Membrane (DLAM). Artacent®
Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
Atracent®, 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.
Standard of Care
Standard of Care: sharp debridement, offloading, and proper moisture balance.
No interventions assigned to this group
Interventions
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Dual Layer Amniotic Membrane (DLAM). Artacent®
Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
Atracent®, 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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
3. At randomization 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 Tissue Analytics photographic planimetry App.
4. 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.
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. The target ulcer must be full thickness without exposed bone.
7. 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:
1. ABI between 0.7 and ≤ 1.3;
2. TBI ≥ 0.6;
3. TCOM ≥ 40 mmHg;
4. PVR: biphasic.
Exclusion Criteria
10. The subject must consent to using the prescribed off-loading method for the duration of the study.
11. The subject must agree to attend the weekly study visits required by the protocol.
12. The subject must be willing and able to participate in the informed consent process.
1. A subject known to have a life expectancy of \< 6 months is excluded.
2. The subject is excluded if the target ulcer is not secondary to diabetes.
3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
9. 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.
10. The subject is excluded if the surface area measurement of the Target ulcer decreases by 40% or more during the 4-week screening phase: the 4 weeks from the initial screening visit (SV1) to the TV-1/randomization visit during which time the subject received SOC.
11. A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
13. A potential subject with end stage renal disease requiring dialysis is excluded.
14. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.
15. A subject who in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
16. 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.
17. A Subject is excluded if the MolecuLight Device shows a positive fluorescence image in the wound bed on TV1
18 Years
ALL
No
Sponsors
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Tides Medical
INDUSTRY
SerenaGroup, Inc.
NETWORK
Responsible Party
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Principal Investigators
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Thomas E Serena, MD,FACS
Role: PRINCIPAL_INVESTIGATOR
Serena Group, Inc
Locations
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Titan Research
Phoenix, Arizona, United States
New Hope Podiatry
Los Angeles, California, United States
Royal Research
Pembroke Pines, Florida, United States
Pharma Research Associates
Westchester, Florida, United States
Regional Infectious Disease and Infusion Center, Inc
La Grange, Georgia, United States
Hoosier Foot and Ankle
Fishers, Indiana, United States
Serena Group Baton Rouge
Baton Rouge, Louisiana, United States
Opelousas Medical Research Consultants, LLC
Opelousas, Louisiana, United States
Mount Sinai St. Luke's Hospital
New York, New York, United States
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, United States
Heal Foundation
Tulsa, Oklahoma, United States
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, United States
Armstrong County Memorial Hospital - Wound Clinic
Kittanning, Pennsylvania, United States
Martin Foot and Ankle
York, Pennsylvania, United States
Mt.Olympus Medical Research
Sugar Land, Texas, United States
Clinical Research Management Group
Coto Laurel, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HITIDE
Identifier Type: -
Identifier Source: org_study_id
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