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

Status Withdrawn

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05024656
Study type	Interventional
Source	Integra LifeSciences Corporation
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2021
Completion date	June 2024

View Details

See also
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