Diabetic Foot Ulcer, Lower Extremity Wound
Conditions
Keywords
Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute
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.
Interventions
OTHERDermACELL AWM
Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
Sponsors
LifeNet Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM). | 112 Days | Days required for granular bed formation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed