An interventional study of PuraPly® Antimicrobial Wound Matrix and SOC for Pressure Ulcers in Chronic Pressure Ulcers, sponsored by Organogenesis. Terminated at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Organogenesis · Not applicable, Interventional, and Other
Among 152 studies in Pressure Ulcer with a site in United States — 25 open to participants now, 29 under way, none of them phase 3. Pressure Ulcer · United States.
Among the 152 studies in Pressure Ulcer with a site in United States, this one is the 65th largest by enrollment of the 118 interventional ones that give a count, is one of 7 that started in 2018, is one of 88 with no phase, and was the 95th registered.
545 studies on the registry are indexed under Pressure Ulcer; 128 are open to participants now.
Browse Pressure Ulcer studies →25 of the 152 studies in Pressure Ulcer with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18–70 · Healthy volunteers
Sequence LifeScience, Inc. · Sites in United States
Ages 18+
NuScience Medical Biologics, LLC · Sites in United States
Ages 18+
North Carolina State University · Sites in United States
Ages 18–75
Biocomposites Ltd · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 61 Pressure Ulcer studies recruiting now, 45 (74%) set no upper age limit and 6 (10%) stop at 75 or younger; 10 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
152 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 11 · Phase 3 3 · Phase 4 12
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Median enrollment 48 across the 118 interventional studies, 135 across the 33 observational. Of the 93 that completed or were terminated, 38 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
72 of 152 have an industry lead sponsor. The 10 most frequent:
Organogenesis is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Organogenesis has 4 studies filed under Pressure Ulcer — fewer than ten, so there is no comparison to draw.
11 of the studies in Pressure Ulcer with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05496296ULURU Inc.Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries | 2026-12 |
| NCT07158658NuScience Medical Biologics, LLCProspective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers | 2026-12-01 |
| NCT07653165West Boca Center for Wound HealingUse of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds | 2026-12-31 |
| NCT04726306Northwell HealthDiagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System | 2026-12-31 |
| NCT05458947Wake Forest University Health SciencesPhysical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI) | 2027-01 |
Add all 11 to your calendar (.ics) → With an account.
Among the 152 studies in Pressure Ulcer with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage II-IV Pressure Ulcers through a prospective randomized controlled study design.
Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure and participation may continue up to 24 weeks. Subjects that are randomized to the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their index ulcer has not healed; they will then be followed for an additional 12 weeks for up to 24 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: PuraPly® Antimicrobial Wound Matrix
Other: SOC for Pressure Ulcers
PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.
Also known as: PuraPly® AM
SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.
Reduction in size of ulcer area between groups
As measured from change in size from baseline
Time frame: Up to 24 weeks
Improvement in wound bed condition between groups
As measured from change in status from baseline
Time frame: Up to 24 weeks
Time to complete wound closure between both groups
As measured by time to complete wound closure from baseline
Time frame: Up to 24 weeks
Improvement in patient reported pain
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Time frame: Up to 24 weeks
Improvement in patient reported quality of life
As measured by change in status from baseline as assessed by the Wound QoL (W-QoL), questionnaire on quality of life with chronic wounds
Time frame: Up to 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Sep 2021, 40 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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