Last updated on July 2018

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

Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT03044132

Contact Investigators or Research Sites near you

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Peter Moyer, DPM

Purvis Moyer Foot and Ankle Center
Rocky Mount, NC United States
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Recruitment Status: Open

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