Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Inclusion Criteria:

1. 18 to 85 years of age;
2. Stage 2, 3, or 4 Pressure Injuries;
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, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

Exclusion Criteria:

1. Known allergy or hypersensitivity to TPD or its components;
2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
3. Heavily exudative wounds;
4. Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
5. Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);
6. Body Mass Index (BMI) \>45 kg/m2;
7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);
9. Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
10. Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
11. Wounds with necrosis unable to undergo prior definitive debridement;
12. Fistulas;
13. Active gangrene;
14. Untreated HIV;
15. Currently pregnant or lactating;
16. Impending organ transplant;
17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
18. Unwilling or unable to comply with offloading recommendations;
19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:

    1. Unable to keep research appointments;
    2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
    3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
    4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
    5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
    6. Not suitable for study participation. -