NCT05024656

AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers

A Prospective, Multi-Center, Randomized Controlled, Parallel Group, Trial Evaluating the Use of AmnioExcel Plus Placental Allograft Membrane for the Management of Diabetic Foot Ulcers

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).

Detailed description

This study will have three (3) phases: (1) a Screening Phase, (2) a Treatment Phase, and (3) a Follow-up Phase. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects who achieve confirmed wound closure during the Treatment Phase will be entered into the Follow-up Phase and will return to the site four (4) weeks following that confirmation visit.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	AmnioExcel Plus Amniotic Membrane	AmnioExcel® Plus will be applied weekly, in conjunction with SOC, if the ulcer remains open, or up to and including Week 11, whichever comes first.
OTHER	Standard of Care	The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-02-01
• Completion: 2024-06-01
• First posted: 2021-08-27
• Last updated: 2021-11-02