An observational study in Partial Thickness Wound, Pressure Ulcer and Venous Ulcer, sponsored by Organogenesis. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Organogenesis · Observational
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 13th largest by enrollment of the 33 observational ones that give a count, is one of 11 that started in 2017, is one of 33 observational ones, and was the 87th 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 and older · 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. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 310 is above the median of 138 across 110 observational 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.
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings as it leads to an improvement in wound bed condition (i.e increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of exudate).
The RESPOND Registry is a prospective, non-interventional research initiative to collect information on patients who are eligible to receive PuraPly™ AM, and no interventional procedures will be mandated by this protocol.
Enrolled and eligible patients will receive standard wound care clinical assessments and any additional care as determined by the treating wound care clinician. Although multiple wounds may be treated simultaneously, one wound will be identified as the target wound, and characteristics regarding this wound will be consistently documented.
The case series is being undertaken to better understand PuraPly™ AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 24 weeks following application of PuraPly™ AM.
Approximately 300 patients to be enrolled by approximately 30 US-based Physician Investigators. Patients are male or female at least 18 years old, with an eligible target wound that meets the Investigator's wound specific treatment goals; including the management of bioburden, support of granulation tissue formation, and support of wound closure.
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.
Patient has a wound appropriate for receiving PuraPly™ AM, including:
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.
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.
Also known as: PuraPly™ Antimicrobial, PuraPly™ AM
Reduction in size of wound area
As measured from change in size from baseline
Time frame: Up to 24 weeks
Time to complete wound closure
As measured by time to complete wound closure from baseline
Time frame: Up to 24 weeks
Improvement in wound bed condition
As measured from change in status 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 SF-12 QoL.
Time frame: Up to 24 weeks
Plan to share: Undecided
Ran from Feb 2017 to primary completion in Jul 2018, 16 months.
Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.