This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
California 1
Fresno, California, United States
California 3
Fresno, California, United States
California 2
Los Angeles, California, United States
Georgia 1
Gainesville, Georgia, United States
The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Time frame: Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported
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* Coban™ * Conforming gauze * Optifoam® non-adhesive dressing * Cotton Gauze * Normal saline (liquid or gel) * Non-adhering dressings * Steristrips * An offloading boot (Pneumatic Short Leg Walker), as appropriate
Illinois 1
Springfield, Illinois, United States
New Jersey 1
Toms River, New Jersey, United States
Texas 1
San Antonio, Texas, United States