Eligibility |
Inclusion Criteria:
- Subject is at least 18 years old and female subjects are not pregnant
- Subject is diagnosed as having Type 1 or Type 2 diabetes
- Presence of a DFU, Wagner 1 or 2, extending at least through the dermis, provided it
is below the level of the medial or lateral malleolus
- Target wound will be located on the foot or ankle and will be the largest ulcer if two
or more DFUs are present with the same Wagner grade and will be the only one evaluated
in the study. If other ulcerations are present on the same foot, they must be more
than 2cm distant from the target wound.
- Study ulcer has been present for at least 1 month and less than or equal to 12 months
as of the date the subject signs consent for study
- Study ulcer size is a minimum of 1.0 cm2 and a maximum of 100.0 cm2
- Study ulcer may have characteristics that include yellow/white slough with or without
fibrous/scar tissue and/or non-viable tissue, but not mandatory
- Subject understands and is willing to participate in the clinical study including
offloading prior to study start, participate in the informed consent process, and can
comply with weekly visits and the follow-up regimen
- Willing and able to comply with study procedures, including study visits and study
dressing regimens
- Subject has read and signed the IRB-approved Informed Consent Form before screening
procedures are undertaken
Exclusion Criteria:
- Study ulcer deemed by the Investigator to be caused by a medical condition other than
Diabetes
- Study ulcer exhibits clinical signs and symptoms of infection, as evidenced by tissue
necrosis, redness, pain, and/or purulent drainage and/or receiving systemic
antibiotics for the treatment of such
- Study ulcer is treated with a topical antibiotic during the screening phase
- Study ulcer requires enzymatic debridement during the study
- Study ulcer is less than 2.0 cm2 or greater than 100.0cm2
- Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or
Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within
the last 30 days
- Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the
course of the trial
- Study ulcer decreases in area by 30% or more during the 14 days screening period
- Presence of any condition(s) that seriously compromises the subject's ability to
complete this study.
- Subjects with a BMI>65
- Subject is an active smoker
- Subject has any history of fish allergy or a known sensitivity to any of the SoC
materials which come into contact with the skin
- Subject is on Dialysis
- Any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in
remission for at least 1 year: bone cancer of metastatic disease of the affected limb,
or has had chemotherapy within the last 12 months
- Suspicion of malignancy. If a clinical suspicion of malignancy exists in the opinion
of the Investigator, a biopsy should be performed regardless of duration of wound.
- Life expectancy < 6 months
- Subject has received within 28 days of screening a treatment which is known to
interfere with or affect the rate and quality of wound healing (e.g., thrombolysis,
systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis,
radiation therapy, chemotherapy, revascularization surgery) and who may receive such
medications during the screening period or who has anticipated to require such
medications during the course of the study
- History of immunodeficiency or any illness or condition that could interfere with
wound healing e.g., lymphedema, end-stage renal disease, severe malnutrition, liver
disease, aplastic anemia. Raynaud's Syndrome, connective tissue disorder, acquired
immune deficiency syndrome, connective tissue disorder, acquired immune deficiency
syndrome, HIV positive, or sickle cell anemia
- Untreated osteomyelitis or bone infection of the affected foot as verified by x-ray
within 30 days prior to treatment. (In the event of an ambiguous diagnosis, the
subject will not be enrolled)
- Hepatitis
- Acute deep venous thrombosis
- Allergy to lidocaine and/or epinephrine
- Subject's inability to safely ambulate with the use of the study-required off-loading
method
- Subject has unstable Charcot foot or Charcot with bone exposed that could inhibit
wound healing
- All females of childbearing potential who are not using a highly effective method of
birth control (failure rate less than 1% per year), such as implants, injectables,
combined oral contraceptives, some IUDs, practice sexual abstinence or have a
vasectomized partner.
- The following are prohibited within 30 days prior to randomized treatment and
throughout the study: Heat lamps, UV lights, Whirlpool baths, Hyperbaric oxygen, Jet
water streams (other than gentle saline irrigation)
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