Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

January 31, 2014 updated by: Healthpoint

A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes:

  1. to identify new adverse events,
  2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
  3. to record wound status, and
  4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.

Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
    • Ontario
      • Hamilton, Ontario, Canada, L8R2R3
      • London, Ontario, Canada, N6C5J1
      • Sudbury, Ontario, Canada, P3E5J1
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
      • Phoenix, Arizona, United States, 85012
      • Phoenix, Arizona, United States, 85006
      • Tucson, Arizona, United States, 85724
      • Tucson, Arizona, United States, 85723
    • California
      • Carlsbad, California, United States, 92009
      • Castro Valley, California, United States, 94546
      • Laguna Hills, California, United States, 92653
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92013
      • San Francisco, California, United States, 94115
      • Stockton, California, United States, 95204
      • Sylmar, California, United States, 91342
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Gainesville, Florida, United States, 32605
      • Hialeah, Florida, United States, 33013
      • Miami, Florida, United States, 33125
      • South Miami, Florida, United States, 33143
      • Tamarac, Florida, United States, 33321
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60616
      • Jacksonville, Illinois, United States, 62650
      • North Chicago, Illinois, United States, 60064
      • Springfield, Illinois, United States, 62702
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Cambridge, Massachusetts, United States, 02138
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Jersey
      • Emerson, New Jersey, United States, 07630
    • New York
      • New York, New York, United States, 10025
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Akron, Ohio, United States, 44307
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74127
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
      • Wyomissing, Pennsylvania, United States, 19610
    • Texas
      • Dallas, Texas, United States, 75390
      • Fort Worth, Texas, United States, 76104
      • Fort Worth, Texas, United States, 76107
      • San Antonio, Texas, United States, 78229
    • Utah
      • St. George, Utah, United States, 84770
    • Virginia
      • Roanoke, Virginia, United States, 24013
    • Washington
      • Tacoma, Washington, United States, 98431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.

Description

Inclusion Criteria:

  • Provide informed consent document
  • Subject was randomized in 802-247-09-029 and received at least one application of a test article.
  • Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.

Exclusion Criteria:

  • Subjects who refuse to provide written informed consent will be excluded from this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: 12 months
The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Objectives
Time Frame: 12 Months
The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthpoint

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 802-247-09-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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