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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01658618
First received: August 1, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Venous Leg Ulcer
Biological: HP802-247

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Primary Objective [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Exploratory Objectives [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 440
Study Start Date: September 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658618

  Hide Study Locations
Locations
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
United States, 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
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, 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
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60616
Jacksonville, Illinois, United States, 62650
North Chicago, Illinois, United States, 60064
Springfield, Illinois, United States, 62702
United States, Maryland
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston, Massachusetts, United States, 02118
Cambridge, Massachusetts, United States, 02138
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Emerson, New Jersey, United States, 07630
United States, New York
New York, New York, United States, 10025
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Akron, Ohio, United States, 44307
United States, Oklahoma
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Dallas, Texas, United States, 75390
Fort Worth, Texas, United States, 76104
Fort Worth, Texas, United States, 76107
San Antonio, Texas, United States, 78229
United States, Utah
St. George, Utah, United States, 84770
United States, Virginia
Roanoke, Virginia, United States, 24013
United States, Washington
Tacoma, Washington, United States, 98431
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
Hamilton, Ontario, Canada, L8R2R3
London, Ontario, Canada, N6C5J1
Sudbury, Ontario, Canada, P3E5J1
Canada, Quebec
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Chief Medical Officer
Study Director: Tommy Lee, MSHS Associate Director Clinical Operations
Principal Investigator: Robert Kirsner, MD Investigator
Principal Investigator: William Marston, MD Investigator
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01658618     History of Changes
Other Study ID Numbers: 802-247-09-030
Study First Received: August 1, 2012
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
Venous leg ulcer
ulcer
venous stasis
compression
venous
venous stasis ulcer
vlu
hp802-247-09-029

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014