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:
- Men or non-pregnant and non-lactating women 18 to 85 years of age;
- Stage 2, 3 and 4 pressure injury (PrI);
- Wound exudate is mild to moderate;
- No clinically active wound infection (clinical diagnosis);
- Able and willing to provide written (not proxy) informed consent;
- Clinically stable.
You may not be eligible for this study if the following are true:
-
- Known allergy or hypersensitivity to TPD;
- Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- Heavily exudative wounds;
- Wound infection (clinical diagnosis);
- Fistulas;
- Received immunosuppression or biologics in the last three months and/or is expected to receive either at any point during the study;
- Wounds with necrosis unable to undergo prior definitive debridement;
- Active gangrene;
- HIV positive;
- Venous stasis disease or lymphedema in the affected limb, if wound is located on the limb;
- Moderate to severe chronic limb ischemia;
- Impending organ transplant;
- Active alcohol or substance abuse (cocaine, heroin or other substances);
- Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
- Poorly controlled diabetes with HgbA1C >12;
- Body Mass Index (BMI) >50 kg/m2.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.