Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

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 betweenthe 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 foreligibility by an independent assessor using a central online review process thatincludes images of the ulcer.
• For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosenas 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 thefirst day of screening (i.e., day -14). Subjects will need to meet all inclusioncriteria, 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 woundinfection at the screening visit may be treated and re-screened for participation inthe 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 leastone of the following: (a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2; (b) toepressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusionpressure (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 tocreate the RD1.
• Female subjects who are capable of conceiving and all males capable of inseminationmust use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pillsor 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 pressureulcers.).
• Presence of underlying osteomyelitis.
• Patient with a proven sepsis established by a blood culture in the past 2 weeks, orconfirmed active infection likely to interfere with trial, such as urine tractinfection.
• History of alcohol or substance abuse, within the previous 2 months
• Subject has participated in another clinical trial involving a device or asystemically administered investigational study drug or treatment within 30 days ofrandomization visit.
• Subject is currently receiving (i.e., within the past 30 days) or scheduled to receivea medication or treatment which, in the opinion of the Investigator, is known tointerfere with, or affect the rate and quality of, wound healing (e.g., systemicsteroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapywithin 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, engineeredtissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®,OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduledto receive during the study.
• Subject has been treated with hyperbaric oxygen within 5 days of screening or isscheduled 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 arecognitively impaired and clearly do not understand the contents of the informedconsent 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 givenintravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) willnot be excluded.
• Hemoglobin anemia (< 10 g/dL).
• Subject has a history of or any of the following intercurrent illnesses or conditionsthat 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) andstandard of care phase, or if the ulcer area increases ≥ 30%, subject will beexcluded.
• Women who are pregnant or currently breast feeding.