DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

Clinical Trial Description

This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).

A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.

The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03044132
Study type	Interventional
Source	LifeNet Health
Contact
Status	Completed
Phase	N/A
Start date	January 15, 2017
Completion date	December 31, 2018

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See also
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