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

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: Unknown
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Device: Apligraf

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apligraf	Device: Apligraf

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in average VLU-related pain at Week 5.		Day 0 - Week 5
Reduction in VLU-related pain using both maximum and average pain	From baseline (Day 0) to Weeks 1, 2, 3 and 4	Day 0 - Weeks 1, 2, 3, and 4

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: 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

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 13-VLU-003-AG