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New treatment option for Pressure Ulcers Stage II
Official title Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
ClinicalTrials.gov ID: NCT05496296
What this study is testing
- What it's testing
- Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 18 to 85 years of age;
- Stage 2, 3, or 4 Pressure Injuries;
- Wound exudate is mild to moderate;
- No clinically active wound infection (clinical diagnosis);
- Able and willing to provide written (not proxy) informed consent;
You likely can't join if
- Known allergy or hypersensitivity to TPD or its components;
- Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- Heavily exudative wounds;
- 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...
- Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);
- Body Mass Index (BMI) \>45 kg/m2;
See the full eligibility criteria
- 18 to 85 years of age;
- Stage 2, 3, or 4 Pressure Injuries;
- 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, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.
- Known allergy or hypersensitivity to TPD or its components;
- Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- Heavily exudative wounds;
- 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;
- Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);
- Body Mass Index (BMI) \>45 kg/m2;
- Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
- Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);
- Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
- 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;
- Wounds with necrosis unable to undergo prior definitive debridement;
- Fistulas;
- Active gangrene;
- Untreated HIV;
- Currently pregnant or lactating;
- Impending organ transplant;
- Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
- Unwilling or unable to comply with offloading recommendations;
- If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:
- Unable to keep research appointments;
- Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
- Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
- Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
- Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
- Not suitable for study participation. -
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Newark, New Jersey, United States
- Lake Success, New York, United States
- Mineola, New York, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Newark, New Jersey, United States; Lake Success, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.