NCT03044132

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

A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: LifeNet Health · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Foot Ulcer
• Lower Extremity Wound

Interventions

Type	Name	Description
OTHER	DermACELL AWM	Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

Timeline

• Start date: 2017-01-15
• Primary completion: 2018-04-30
• Completion: 2018-12-31
• First posted: 2017-02-06
• Last updated: 2019-09-06

Locations

2 sites across 1 country: United States