PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV… (NCT03502824) | Clinical Trial Compass
TerminatedNot Applicable
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
Stopped: slow enrollment
United States40 participantsStarted 2018-05-01
Plain-language summary
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
Who can participate
Age range
18 Years – 99 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
. Subject must be at least 18 years of age.
. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area \> 2cm2
. If multiple ulcers are present, one ulcer must be identified as the index ulcer.
. The index ulcer is free from active infection at the time of randomization.
. Willingness to off-load or pressure redistribute ulcer for duration of enrollment
. The index ulcer has been offloaded for at least 7 days prior to randomization.
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.
. The index ulcer must have been present for at least 30 days at time of study enrollment.
Exclusion criteria
. Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection
. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
. Non-enteric or unexplored sinus tract
. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
. Subject has a known sensitivity to porcine materials
. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)