WUH: A Prospective Multicenter Randomized Controlled Clinical Study Of NuShield and Standard of Care (SOC) compared to SOC alone For The Management Of Diabetic Foot Ulcers

Are you eligible to participate in this study?

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

  • Conditions:
    Diabetic Foot Ulcers
  • Age: Between 18 - 85 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are between the ages of 18-85
    2. Subjects with diabetic foot ulcers which extend into the papillary (shallow) dermis, or into the reticular (deep) dermis, or into subcutaneous fat, but not extending into muscle, tendon, capsule, or bone.
    3. Subjects, with the presence of Diabetes, must have a Glycosylated hemoglobin (HbA1c) = 12% within 4 weeks prior to randomization
    4. Subjects have index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit with no upper limit in duration of non-healing.
    5. Subject has adequate circulation to the foot
    6. Subjects have index ulcer is a minimum of 0.5 cm2 and a maximum of 25cm2 at Randomization
    7. Subjects have index ulcer has been offloaded for 14 days prior to randomization
    8. Subjects have index ulcer has not reduced in area > 20% from Day -14 to Day 0
    9. Subjects understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen
    10. Subjects, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

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

    1. Subjects with index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
    2. Subjects with treatment with HBO wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of randomization.
    3. Subjects with history of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
    4. Subjects with a history of more than two weeks treatment with immunosuppressants
    5. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit
    6. Subjects with history of radiation at the ulcer site.
    7. Subjects with index ulcer has been previously treated or will need to be treated with any prohibited therapies within 30 days prior to randomization
    8. Subjects with any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
    9. Subjects with acute osteomyelitis or bone infection of the affected foot
    10. Subjects unwilling or unable to comply with the study requirement for offloading the index wound
    11. Subjects are pregnant or lactating



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