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 range18 Years – 99 Years
SexALL
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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.
✓. 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