- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457752
Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)
A Randomised Controlled Multicentre Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care Versus Standard of Care Alone in the Healing of Chronic Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted the phrase, "time is tissue." This adage reminds clinicians that the longer a DFU remains open, the greater the risk of infection, major amputation and death. The diabetic with a foot ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3. Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15 billion dollars annually4.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Thomas E Serena, MD,FACS
- Phone Number: 814-688-4000
- Email: serena@serenagroups.com
Study Contact Backup
- Name: Doug Payne
- Phone Number: 888-494-4441
- Email: dpayne@tidesmedical.com
Study Locations
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Coto Laurel, Puerto Rico, 00780
- Completed
- Clinical Research Management Group
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Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Titan Research
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Contact:
- Kwadjo Walker
- Email: kwalker@viableresearch.org
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Contact:
- Noreen Rana
- Email: nrana.alas@viableresearch.org
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California
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Los Angeles, California, United States, 90063
- Recruiting
- New Hope Podiatry
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Contact:
- Francis Morfin
- Email: francis_morfin@yahoo.com
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Contact:
- Demitric Lopez
- Email: demitriclopez@gmail.com
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Principal Investigator:
- Charles E Ananian, DPM
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Florida
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Pembroke Pines, Florida, United States, 33027
- Recruiting
- Royal Research
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Contact:
- Yalily Perez
- Email: yalilyp@royalresearchcorp.com
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Contact:
- Yaili Perez
- Email: yailip@royalresearchcorp.com
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Principal Investigator:
- Melissa Perlman, DPM
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Westchester, Florida, United States, 33155
- Completed
- Pharma Research Associates
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Georgia
-
LaGrange, Georgia, United States, 30240
- Recruiting
- Regional Infectious Disease and Infusion Center, Inc
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Contact:
- Bhuvan Doneepudi, MS
- Email: bhuvan@nobadbugs.com
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Principal Investigator:
- Ravi Kamepalli@nobadbugs.com
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Indiana
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Fishers, Indiana, United States, 46037
- Recruiting
- Hoosier Foot and Ankle
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Contact:
- Cheri Britt
- Email: cheribhfa@outlook.com
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Contact:
- James Vestile, DPM
- Email: jvestile@gmail.com
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Principal Investigator:
- James Vestile, DPM
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Louisiana
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Baton Rouge, Louisiana, United States, 70806
- Recruiting
- Serena Group Baton Rouge
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Contact:
- Thomas E Serena, MS, FACS
- Email: serena@serenagroups.com
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Contact:
- Khristina Serena
- Email: kserena@serenagroups.com
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Principal Investigator:
- Thomas Serena, MD,FACS
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Opelousas, Louisiana, United States, 70570
- Recruiting
- Opelousas Medical Research Consultants, LLC
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Contact:
- Kerry Thibodeaux, MD
- Email: KerryThibodeaux1960@gmail.com
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Contact:
- Marcus Speyrer
- Email: mspeyrer@thewoundtreatmentcenter.com
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Principal Investigator:
- Kerry Thibodeaux, MD
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New York
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New York, New York, United States, 10025
- Recruiting
- Mount Sinai St. Luke's Hospital
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Contact:
- Denise Alabi
- Email: Denise.Alabi@mountsinai.org
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Principal Investigator:
- John Lantis, MD
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Ohio
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Cleveland, Ohio, United States, 44103
- Recruiting
- Cleveland Foot and Ankle Clinic
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Contact:
- Windy Cole, DPM
- Email: drwec@yahoo.com
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Contact:
- Stacey Coe
- Email: scoe3@kent.edu
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Principal Investigator:
- Windy Cole, DPM
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Oklahoma
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Tulsa, Oklahoma, United States, 74146
- Recruiting
- Heal Foundation
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Contact:
- Lam Le, MD
- Email: lam.le@sjmc.org
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Contact:
- Phil Salon
- Email: philbert.salon@gmail.com
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Principal Investigator:
- Lam Le, MD
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Pennsylvania
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Ford City, Pennsylvania, United States, 16226
- Recruiting
- The Foot and Ankle Wellness Center of Western Pennsylvania
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Contact:
- Nicole Schrecengost
- Phone Number: 724-664-3843
- Email: nschrecengost@serenagroups.com
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Kittanning, Pennsylvania, United States, 16201
- Recruiting
- Armstrong County Memorial Hospital - Wound Clinic
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Contact:
- Bryan Doner, DO
- Email: DrDoner@dandpmedicalgroup.com
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Contact:
- Nicole Schrecengost, LPN
- Email: nschrecengost@serenagroups.com
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Principal Investigator:
- Bryan Doner, DO
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York, Pennsylvania, United States, 17402
- Recruiting
- Martin Foot and Ankle
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Contact:
- Beth Mincer
- Email: beth@martinfootandankle.com
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Principal Investigator:
- Maria Kasper, DMP
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Texas
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Sugar Land, Texas, United States, 77479
- Completed
- Mt.Olympus Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be at least 18 years of age or older,
- Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
- 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.
- 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.
- 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 30 days prior to randomization.
- 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.
Exclusion Criteria:
- 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.
- 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 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.
- 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.
- A Subject is excluded if the MolecuLight Device shows a positive fluorescence image in the wound bed on TV1
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dual Layer Amniotic Membrane (DLAM) + SOC
DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).
|
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. |
No Intervention: Standard of Care
Standard of Care: sharp debridement, offloading, and proper moisture balance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Wound Closure
Time Frame: 1-12 weeks
|
- The percentage of target ulcers achieving complete wound closure in 12 weeks
|
1-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Wound Area Reduction
Time Frame: 1-12 weeks
|
- Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
|
1-12 weeks
|
Adverse Events
Time Frame: 1-12 weeks
|
The number of adverse events
|
1-12 weeks
|
Percentage of time wearing offloading boot
Time Frame: 1-12 Weeks
|
- Compliance with a prescribed offloading boot measured as % of time wearing the boot
|
1-12 Weeks
|
Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine
Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
|
- Change in pain in the target ulcer assessed using the PEG scale.
[Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit]
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TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
|
Changes in bacterial Load
Time Frame: 1-12 Weeks
|
- Exploratory Endpoint: changes in bacterial load measured using fluorescence imaging
|
1-12 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas E Serena, MD,FACS, Serena Group, Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HITIDE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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