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

September 3, 2019 updated by: LifeNet Health

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93710
        • Limb Preservation Platform
    • North Carolina
      • Rocky Mount, North Carolina, United States, 27804
        • Purvis Moyer Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: DermACELL AWM
Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
Time Frame: 112 Days
Days required for granular bed formation
112 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of applications of study product required to achieve granulation.
Time Frame: 16 Weeks
16 Weeks
Percent wound area reduction and percent complete wound closure at 16 Weeks.
Time Frame: 16 Weeks
16 Weeks
The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeNet Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (ESTIMATE)

February 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-16-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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