NCT03547635

AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

A Prospective, Multi-Center, Randomized, Parallel-group Study Comparing AMNIOEXCEL Plus Placental Allograft Membrane to a Marketed Comparator and Standard of Care Procedures in the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	AMNIOEXCEL Plus Amniotic Membrane	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.
DEVICE	A Marketed Comparator	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.
OTHER	Standard of Care	* 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

Timeline

• Start date: 2018-05-03
• Primary completion: 2019-02-26
• Completion: 2019-02-26
• First posted: 2018-06-06
• Last updated: 2020-07-20
• Results posted: 2020-07-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study