Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
Condition: Neuropathic Diabetic Ulcer - Foot
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: RedDress Wound Care System (RD1)
Intervention description: Weekly application. A blood based wound care treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Autologous Blood Clot Product was applied to all patients
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer; Diabetic Ulcer; Diabetic Wound; Chronic Ulcer; Chronic Wound; Neuropathic Diabetic Foot Ulcer; Neuropathic DFU; DFU

Summary:

      The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in
      patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
    

Eligibility criteria:

        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.