A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®

December 10, 2013 updated by: Organogenesis

An Open Label, Multi Center, Post Marketing Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®

The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
100

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.
  • Phase 4

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
      • Mineola, New York, United States, 11501
        • Winthrop University 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is a minimum of 18 years of age.
  • Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
  • Subject is able and willing to follow study procedures and instructions.
  • Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0).
  • Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy.
  • Female subject of childbearing potential has a documented negative urine pregnancy test.
  • Subject (male or female) agrees to use highly effective methods of contraception for the duration of the study.

Exclusion Criteria:

  • Subject has more than 1 VLU.
  • Female subject who is lactating.
  • Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study.
  • Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement).
  • Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of <0.65.
  • Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment.
  • Subject who is scheduled to have a vascular intervention on the study extremity during the study.
  • Subject with a biopsy confirmed active malignancy at the VLU. Also, subject with any active malignancy not at the VLU, with the exception of squamous cell carcinoma or basal cell carcinoma.
  • Subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to Screening visit, topical corticosteroids at the VLU.
  • Subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases.
  • Subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the VLU.
  • Subject has a VLU with an avascular wound bed.
  • Subject has a VLU with exposed bone, tendon, or fascia.
  • Subject has other wounds (DFU, surgical, etc.) on the same limb as the VLU.
  • Subject has a known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
  • Subject previously treated with Apligraf, or any other cell or tissue-based product at the VLU within 30 days of the Screening visit.
  • Subject who, in the opinion of the Investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits).
  • Subject, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group 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.
Experimental: Apligraf
Device: Apligraf

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
Percent reduction in maximum VLU-related pain at Week 5
Time Frame: Day 0 - Week 5
Based on the maximum pain levels during the preceding 24 hours
Day 0 - Week 5

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
Time Frame
Reduction in maximum VLU-related pain at 48 hours following initial Apligraf application
Time Frame: Day 0 - 48 hours after Apligraf application
Day 0 - 48 hours after Apligraf application
Reduction on SF-12v2 - Pain Enhanced Health Survey at Week 5
Time Frame: Day 0 - Week 5
Day 0 - Week 5
Reduction in class and/or dose of VLU-related pain medications at Week 5
Time Frame: Day 0 - Week 5
Day 0 - Week 5
Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5
Time Frame: Day 0 - Week 5
Day 0 - Week 5

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction in average VLU-related pain at Week 5.
Time Frame: Day 0 - Week 5
Day 0 - Week 5
Reduction in VLU-related pain using both maximum and average pain
Time Frame: Day 0 - Weeks 1, 2, 3, and 4
From baseline (Day 0) to Weeks 1, 2, 3 and 4
Day 0 - Weeks 1, 2, 3, and 4

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: William A. Marston, MD, Division of Vascular Surgery, UNC at Chapel Hill
  • Principal Investigator: Scott Gorenstein, MD, Winthrop University Hospital
  • Principal Investigator: David G. Armstrong, DPM, MD, PhD, Department of Surgery, University of Arizona College of Medicine

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

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.
November 1, 2013

Primary Completion (Anticipated)

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.
January 1, 2014

Study Completion (Anticipated)

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 1, 2014

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).
December 10, 2013

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.
December 10, 2013

First Posted (Estimate)

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.
December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
December 13, 2013

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.
December 10, 2013

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.
December 1, 2013

More Information

Terms related to this study

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.
  • 13-VLU-003-AG

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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