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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011724
Recruitment Status : Unknown
Verified December 2013 by Organogenesis.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcers Device: Apligraf Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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®
Study Start Date : November 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Apligraf Device: Apligraf

Primary Outcome Measures :
  1. 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

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

Other Outcome Measures:
  1. Reduction in average VLU-related pain at Week 5. [ Time Frame: Day 0 - Week 5 ]
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02011724

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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
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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

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Responsible Party: Organogenesis Identifier: NCT02011724     History of Changes
Other Study ID Numbers: 13-VLU-003-AG
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases