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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer; Lower Extremity Wound
• Interventions: Other: DermACELL AWM

• Registration Number: NCT03044132
• Lead Sponsor: LifeNet Health

Brief 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.

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Primary Completion: 2018-04-30
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DermACELL AWM	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.

Primary Outcome Measures

Name	Time	Method
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).	112 Days	Days required for granular bed formation

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Limb Preservation Platform; 🇺🇸 Fresno, California, United States

Purvis Moyer Foot and Ankle Center; 🇺🇸 Rocky Mount, North Carolina, United States