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

Phase 4

• Conditions: Venous Leg Ulcers
• Interventions: Device: Apligraf

• Registration Number: NCT02011724
• Lead Sponsor: Organogenesis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apligraf	Apligraf	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 in maximum VLU-related pain at 48 hours following initial Apligraf application	Day 0 - 48 hours after Apligraf application
Reduction on Cardiff Wound Impact Schedule (CWIS) at Week 5	Day 0 - Week 5

Trial Locations

Locations (1)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States