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

LifeNet Health

Status: Completed

Conditions: Lower Extremity Wound; Diabetic Foot Ulcer

Treatments: Other: DermACELL AWM

Study type: Interventional

Funder types: Industry

Identifiers

NCT03044132

CR-16-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
• target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
• target wound that is not amendable to primary closure
• target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
• adequate perfusion to the extremity
• laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)

Exclusion criteria

• untreated infection of soft tissue or bone
• untreated autoimmune connective tissue disorders
• body mass index (BMI) of ≥ 50
• undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
• active liver disease (e.g. hepatitis A-G),
• have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
• pregnant
• enrolled in any other interventional clinical research trial
• an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

DermACELL AWM

Experimental group

Description:

Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.

Treatment:

Other: DermACELL AWM