Phase
Condition
Stasis Dermatitis
Ulcers
Diabetic Foot Ulcers
Treatment
PermeaDerm Biosynthetic Wound Matrix
Frozen Human Cadaveric Allograft (FHCA)
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
The patient's wound requires temporary dressing coverage after surgical excision andprior to autografting.
The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
The study area is a contiguous area. If the patient has other areas (non-studytreatment area) that require temporary dressing, these areas must also be dressedaccording to the randomization.
The patient is hospitalized within 3 days of injury.
The surgical excision occurs within 5 days post-injury.
The patient (or parent/guardian/legally authorized representative) is willing andable to comply with all study procedures and visit schedule.
The patient (or parent/guardian/legally authorized representative) agrees to abstainfrom any other treatment of the study area or enrollment in another interventionalclinical trial for the duration of his/her participation in the study (8 weekspost-autografting).
In the opinion of the investigator, the patient (or parent/guardian/legallyauthorized representative) must be able to:
Understand the full nature and purpose of the study, including possible risksand adverse events,
Understand instructions, and
Provide voluntary written informed consent.
Exclusion
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for participation:
The study area has received prior surgical intervention.
The patient is currently using medications or treatments such as systemiccorticosteroids, chemotherapy, or immunosuppressants, that in the investigator'sopinion may compromise patient safety or trial objectives.
Clinical signs of wound infection at study area that in the investigator's opinionmay compromise patient safety or trial objectives.
The patient has any of the following
morbid obesity (BMI >40),
immunodeficiency,
venous insufficiency/PVD of the lower extremities (when study area is also inthis location),
chronic malnourishment,
inhalation injury (>Grade 1 based on AIS grading scale),
current abuser of alcohol and/or illicit drugs based upon medical historyand/or lab results,
diabetes mellitus with HbA1c >9.0%, and/or
advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upperlimit).
The patient has any another condition, that in the investigator's opinion maycompromise patient safety or the trial objectives.
The patient is unable to understand English or Spanish.
The patient has a known hypersensitivity to bovine-derived collagen materials,porcine, aloe vera materials, or contraindications to the frozen human cadavericallograft.
The patient's life expectancy is less than 1 year.
Study Design
Study Description
Connect with a study center
Valleywise Health
Phoenix, Arizona 85008
United StatesActive - Recruiting
Grady Memorial
Atlanta, Georgia 30303
United StatesSite Not Available
University of Kansas
Kansas City, Kansas 66160
United StatesActive - Recruiting
University Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Akron Children's Hospital
Akron, Ohio 44308
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Regional One Firefighter's Burn Center
Memphis, Tennessee 38163
United StatesSite Not Available
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