DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Completed · Not applicable
Conditions studied: Diabetic Foot Ulcer, Lower Extremity Wound
In brief
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
Key facts
- Study ID
- NCT03044132
- Run by
- LifeNet Health
- People needed
- 61
- Starts
- 2017-01-15
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2019-09-06
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Limb Preservation Platform — Fresno, California, United States
- Purvis Moyer Foot and Ankle Center — Rocky Mount, North Carolina, United States
Full record on ClinicalTrials.gov
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