Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Sta… (NCT05496296) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
United States300 participantsStarted 2023-04-30
Plain-language summary
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. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);