Clinical Research Directory

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. -