The RESPOND Registry (RESPOND)

February 26, 2019 updated by: Organogenesis

Real-World Effectiveness Study of PuraPly™ AM on Wounds

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.

Study Overview

Status

Status

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

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

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.

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.
Observational

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.
310

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
    • Arizona
      • Prescott Valley, Arizona, United States, 86314
        • Advanced Wound Care Center at Yavapai Regional Medical Center
    • Florida
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Miami, Florida, United States, 33155
        • West Gables Rehab Hospital
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Institute for Advanced Wound Healing; Northshore Specialty Hospital
      • Hammond, Louisiana, United States, 70403
        • Wound Care Associates, LLC.
      • Opelousas, Louisiana, United States, 70570
        • Opelousas General Hospital Wound Center
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Saint Louis Foot and Ankle
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • CentraState Medical Center
      • Hamilton, New Jersey, United States, 08690
        • Robert Wood Johnson Hamilton
    • New York
      • Southampton, New York, United States, 11968
        • Southampton Hospital
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Sacred Heart Hospital
      • Harrisburg, Pennsylvania, United States, 17112
        • Harrisburg Foot and Ankle Center, Inc.
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greensville Health System
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Patient is at least 18 years of age.
  • Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).

  • Patient has a wound appropriate for receiving PuraPly™ AM, including:

    • Partial or full-thickness wound
    • Pressure ulcer
    • Venous ulcer
    • Diabetic ulcer
    • Chronic vascular ulcer
    • Tunneled/undermined wound
    • Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence)
    • Trauma wound (abrasions, lacerations, second degree burns, and skin tears)
    • Draining wound

Exclusion Criteria:

  • Patient has a known sensitivity to porcine materials.
  • Patient has a third-degree burn.
  • Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).
  • Patient's target wound was previously treated with PuraPly™ AM.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

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 wound area
Time Frame: Up to 24 weeks
As measured from change in size from baseline
Up to 24 weeks
Time to complete wound closure
Time Frame: Up to 24 weeks
As measured by time to complete wound closure from baseline
Up to 24 weeks
Improvement in wound bed condition
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
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 SF-12 QoL.
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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Continuum Clinical Inc.

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: Adam J Teichman, DPM, PA Foot and Ankle Association
  • Principal Investigator: Shaun Carpenter, M.D., Wound Care Associates, LLC.
  • Principal Investigator: Daniel L Kapp, M.D., Jupiter Medical Center
  • Principal Investigator: Kerry Thibodeaux, M.D., Opelousas General Hospital Wound Center
  • Principal Investigator: George Koullias, M.D., Southampton Hospital
  • Principal Investigator: Raymond Abdo, DPM, Saint Louis Foot and Ankle
  • Principal Investigator: Barry Wisler, DPM, Robert Wood Johnson Hamilton
  • Principal Investigator: Carlos Trabanco, MD, West Gables Rehabilitation Hospital
  • Principal Investigator: Ifat Kamin, MD, Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
  • Principal Investigator: Amanda Estapa, NP, Institute for Advanced Wound Healing; Northshore Specialty Hospital
  • Principal Investigator: Michael Menack, MD, CentraState Medical Center
  • Principal Investigator: Ritu Gothwal, MD, Advanced Wound Care Center at Yavapai Regional Medical Center
  • Principal Investigator: Mark Iafrati, MD, Tufts Medical Center
  • Principal Investigator: Paula Pons, MD, Saint Joseph's Center for Wound Care and Hyperbaric Medicine
  • Principal Investigator: Taysha Howell, MD, Oklahoma Wound Center
  • Principal Investigator: Allan Grossman, DPM, Harrisburg Foot and Ankle Center, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 21, 2017

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.
July 15, 2018

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.
January 26, 2019

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).
August 26, 2017

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.
September 15, 2017

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.
September 18, 2017

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.
February 27, 2019

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.
February 26, 2019

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.
February 1, 2019

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.
  • 16-REG-002-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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