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

Study Overview
=================
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.

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®

Conditions
-----------------
Venous Leg Ulcers

Intervention / Treatment
-----------------
* Device: Apligraf


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apligraf<br> | Device: Apligraf<br> <br> |

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 | Measure Description | 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 |