Last updated on April 2017

Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Venous Ulcers | Pressure Ulcers | Diabetic Foot Ulcers
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Medicare Eligible
    Written informed consent obtained from either the subject or the subject's legally
    acceptable representative prior to screening activities
    Male or female ≥ 18 years of age
    Duration of Diabetic Foot Ulcers (DFU),Venous Ulcers (VU), or Pressure Ulcers (PU) is
    greater than 30 days at first visit/subject screening
    DFU is classified as Wagner 1 -2 on the Wagner classification system
    If more than one non-healing wound is present, the largest of the wounds that is
    classified as a Wagner 1 - 2.
    If a subject has multiple eligible wounds, the largest wound will be selected. There
    must be at least 4 cm between the index wound and other wounds; if all wounds are
    closer than 4 cm, the subject should not be enrolled (screen failure).
    The ulcer must be clinically non-infected
    Able and willing to comply with the procedures required by the protocol. Subjects may
    be managed as either inpatient or outpatient.
    If a female of childbearing potential, the subject must have a negative urine
    pregnancy test at screening and must agree to use adequate contraception methods for
    the duration of the study.
    Ankle Brachial Index (ABI) greater than or equal to 0.7.

You may not be eligible for this study if the following are true:

  • Subjects with known sensitivity to components of the Arteriocyte BioBandage™ (calcium
    chloride, thrombin, acid citrate dextrose solution A (ACDA)).
    Current treatment of another chronic wound in the same limb (defined as arm or leg).
    Wound is not of DFU, PU, or VU pathophysiology.
    PU is classified as late stage III or stage IV.
    Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
    Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen
    therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived
    products for wounds during the 30 days preceding the screening visit.
    Any chronic condition requiring the use of systemic corticosteroids 30 days prior to
    tudy entry and anytime during the course of the study.
    Received radiation therapy or chemotherapy within previous 6 months.
    Any malignancy other than non-melanoma skin cancer.
    Patient has radiographic evidence consistent with diagnosis of neuropathic
    osteoarthropathy (Charcot foot) in the treatment limb.
    Ulcer area decreases by greater than or equal to 30% during screening period
    Subjects who are cognitively impaired and do not have a healthcare proxy.
    Subject has inadequate venous access for repeated blood draw required for PRP
    Subject has sickle cell anemia.
    Subject is pregnant or plans to become pregnant during the duration of the trial.
    Concurrent participation in a clinical trial in which an investigational agent is
    Females who are nursing.
    Subjects with Thrombocytopenia < 100,000 platelets/µL.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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