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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: February 14, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show 43 Study Locations
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: February 14, 2013
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 May 16, 2013