- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Fresno, California, United States, 93710
- Limb Preservation Platform
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North Carolina
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Rocky Mount, North Carolina, United States, 27804
- Purvis Moyer Foot and Ankle Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
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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
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112 Days
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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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-16-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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