| Eligibility |
Inclusion Criteria:
- Subject is =18 years of age and has type 1 or 2 diabetes
- Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between
the toes but including those of the heel) and depth = 5 mm with no exposed capsule,
tendon or bone and no tunneling, undermining or sinus tracts
- Prior to inclusion of an ulcer in the study, each wound will be reviewed for
eligibility by an independent assessor using a central online review process that
includes images of the ulcer.
- For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen
as the study ulcer.
- Ulcer size between 1 cm2 and 12 cm2 (post-debridement).
- Ulcer duration of = 30 days. Time 0 for ulcer duration of = 30 days is defined as the
first day of screening (i.e., day -14). Subjects will need to meet all inclusion
criteria, including lack of ulcer healing until day 0.
- Study ulcer separated from other ulcers by at least 2 cm.
- Ulcer or affected limb free of clinical signs of infection. (Subjects with wound
infection at the screening visit may be treated and re-screened for participation in
the study after eradication of the infection).
- Post-debridement, ulcer free of necrotic tissue.
- Subject has adequate vascular perfusion of the affected limb, as defined by at least
one of the following: (a) Ankle-Brachial Index (ABI) = 0.65 and = 1.2; (b) toe
pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion
pressure (SPP) > 30 mm Hg.
- HbA1c = 12.0% (diabetic patients)
- Demonstrated adequate offloading regimen.
- Subject must be willing to comply with the protocol including having blood drawn to
create the RD1.
- Female subjects who are capable of conceiving and all males capable of insemination
must use an acceptable form of contraception in order to participate in the study
(acceptable forms of contraception include condoms for males and contraceptive pills
or IUDs for women).
Exclusion Criteria:
- Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic,
radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure
ulcers.).
- Presence of underlying osteomyelitis.
- Patient with a proven sepsis established by a blood culture in the past 2 weeks, or
confirmed active infection likely to interfere with trial, such as urine tract
infection.
- History of alcohol or substance abuse, within the previous 2 months
- Subject has participated in another clinical trial involving a device or a
systemically administered investigational study drug or treatment within 30 days of
randomization visit.
- Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive
a medication or treatment which, in the opinion of the Investigator, is known to
interfere with, or affect the rate and quality of, wound healing (e.g., systemic
steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy
within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery,
angioplasty or thrombolysis).
- Subject has been treated with wound dressings that include growth factors, engineered
tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®,
OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduled
to receive during the study.
- Subject has been treated with hyperbaric oxygen within 5 days of screening or is
scheduled to receive during the study.
- Wound on a patient who has a life expectancy of less than 12 months.
- Subjects who are cognitively impaired and have a healthcare proxy or those who are
cognitively impaired and clearly do not understand the contents of the informed
consent form.
- Cannot withdraw blood in the required amount (up to 10 mL per week) technically.
- Known coagulation problems, abnormal thrombocytes level or if heparin is given
intravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) will
not be excluded.
- Hemoglobin anemia (< 10 g/dL).
- Subject has a history of or any of the following intercurrent illnesses or conditions
that would compromise the safety of the subject, or the normal wound healing process:
- End stage renal disease
- Immunosuppression.
- Severe malnutrition
- Liver disease
- Scleroderma
- Acquired immune deficiency disease (AIDS) or HIV positive
- Connective tissue disorder
- Exacerbation of sickle cell anemia
- If ulcer area decreases by = 30% during the initial 2-week screening (± 2 days) and
standard of care phase, or if the ulcer area increases = 30%, subject will be
excluded.
- Women who are pregnant or currently breast feeding.
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