124
Participants
Start Date
September 1, 2020
Primary Completion Date
March 1, 2022
Study Completion Date
March 31, 2023
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."
RECRUITING
Mount Sinai St. Luke's Hospital, New York
RECRUITING
Armstrong County Memorial Hospital - Wound Clinic, Kittanning
RECRUITING
The Foot and Ankle Wellness Center of Western Pennsylvania, Ford City
RECRUITING
Martin Foot and Ankle, York
RECRUITING
Regional Infectious Disease and Infusion Center, Inc, La Grange
RECRUITING
Royal Research, Pembroke Pines
COMPLETED
Pharma Research Associates, Westchester
RECRUITING
Cleveland Foot and Ankle Clinic, Cleveland
RECRUITING
Hoosier Foot and Ankle, Fishers
RECRUITING
Opelousas Medical Research Consultants, LLC, Opelousas
RECRUITING
Serena Group Baton Rouge, Baton Rouge
RECRUITING
Heal Foundation, Tulsa
COMPLETED
Mt.Olympus Medical Research, Sugar Land
RECRUITING
Titan Research, Phoenix
RECRUITING
New Hope Podiatry, Los Angeles
COMPLETED
Clinical Research Management Group, Coto Laurel
Collaborators (1)
Tides Medical
INDUSTRY
SerenaGroup, Inc.
NETWORK