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

NCT02011724 | Unknown Phase 4

• 1 other identifier: 13-VLU-003-AG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Outcomes (2)

• Reduction in average VLU-related pain at Week 5.

  Day 0 - Week 5

• Reduction in VLU-related pain using both maximum and average pain

  Day 0 - Weeks 1, 2, 3, and 4

Study Arms (1)

Apligraf

EXPERIMENTAL

Device: Apligraf

Interventions

Apligraf DEVICE

Apligraf

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

US (1)