Randomized Controlled Open-Label Parallel Group Multi-Center Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2 3 and 4 Pressure Injuries

Are you eligible to participate in this study?

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

  • Conditions:
    Pressure Injury Npiap Stage 2,3, And 4
  • Age: Between 18 Year(s) - 85 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Men or non-pregnant and non-lactating women 18 to 85 years of age;
    2. Stage 2, 3 and 4 pressure injury (PrI);
    3. Wound exudate is mild to moderate;
    4. No clinically active wound infection (clinical diagnosis);
    5. Able and willing to provide written (not proxy) informed consent;
    6. Clinically stable.

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

    1. Known allergy or hypersensitivity to TPD;
    2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
    3. Heavily exudative wounds;
    4. Wound infection (clinical diagnosis);
    5. Fistulas;
    6. Received immunosuppression or biologics in the last three months and/or is expected to receive either at any point during the study;
    7. Wounds with necrosis unable to undergo prior definitive debridement;
    8. Active gangrene;
    9. HIV positive;
    10. Venous stasis disease or lymphedema in the affected limb, if wound is located on the limb;
    11. Moderate to severe chronic limb ischemia;
    12. Impending organ transplant;
    13. Active alcohol or substance abuse (cocaine, heroin or other substances);
    14. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
    15. Poorly controlled diabetes with HgbA1C >12;
    16. Body Mass Index (BMI) >50 kg/m2.



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