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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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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

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Diabetic Foot Ulcer Lower Extremity Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DermACELL AWM

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.

Group Type EXPERIMENTAL

DermACELL AWM

Intervention Type OTHER

Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

Interventions

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DermACELL AWM

Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No