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

  Show 49 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: 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:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014