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

NCT ID: NCT02011724

Last Updated: 2013-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

Venous Leg Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Apligraf

Group Type: EXPERIMENTAL

Apligraf

Intervention Type: DEVICE

Interventions

Apligraf

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William A. Marston, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Vascular Surgery, UNC at Chapel Hill

Scott Gorenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

David G. Armstrong, DPM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Arizona College of Medicine

Locations

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

13-VLU-003-AG

Identifier Type: -

Identifier Source: org_study_id