PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.

September 15, 2021 updated by: Organogenesis

A Prospective, Multicenter, 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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11402
        • Northwell Health
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
  3. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
  4. If multiple ulcers are present, one ulcer must be identified as the index ulcer.
  5. The index ulcer is free from active infection at the time of randomization.
  6. Willingness to off-load or pressure redistribute ulcer for duration of enrollment
  7. The index ulcer has been offloaded for at least 7 days prior to randomization.
  8. The index ulcer must have been present for at least 30 days at time of study enrollment.
  9. The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.
  10. Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.

Exclusion Criteria:

  1. 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
  2. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
  3. Non-enteric or unexplored sinus tract
  4. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
  5. Subject has a known sensitivity to porcine materials
  6. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PuraPly® AM plus Standard of Care
Device: PuraPly® Antimicrobial Wound Matrix
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.
Other Names:
  • PuraPly® AM
Active Comparator: Standard of Care (SOC) for Pressure Ulcers
Other: SOC for Pressure Ulcers
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in size of ulcer area between groups
Time Frame: Up to 24 weeks
As measured from change in size from baseline
Up to 24 weeks
Improvement in wound bed condition between groups
Time Frame: Up to 24 weeks
As measured from change in status from baseline
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in patient reported pain
Time Frame: Up to 24 weeks
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Up to 24 weeks
Time to complete wound closure between both groups
Time Frame: Up to 24 weeks
As measured by time to complete wound closure from baseline
Up to 24 weeks
Improvement in patient reported quality of life
Time Frame: Up to 24 weeks
As measured by change in status from baseline as assessed by the Wound QoL (W-QoL), questionnaire on quality of life with chronic wounds
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organogenesis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Gorenstein, MD FACEP, NYU Winthrop Hospital
  • Principal Investigator: Alisha Oropallo, MD, FACS, APWCA, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-PRU-004-PPAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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