Clinical trial NCT03044132: DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Official title: A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lower Extremity Wound
Keywords: Diabetic Foot Ulcer
DFU
Lower Extremity Wound
Skin Substitute
Lead sponsor: LifeNet Health
Sponsor class: INDUSTRY
First posted: 2017-02-06
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
timeFrame: 112 Days
Secondary outcomes:
measure: Number of applications of study product required to achieve granulation.
timeFrame: 16 Weeks
measure: Percent wound area reduction and percent complete wound closure at 16 Weeks.
timeFrame: 16 Weeks
measure: The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Rocky Mount
country: United States
facility: Purvis Moyer Foot and Ankle Center
state: North Carolina
Study officials:
References:
citation: Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.