We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Healthpoint.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658618
First Posted: August 7, 2012
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Healthpoint
August 1, 2012
August 7, 2012
February 3, 2014
September 2012
March 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01658618 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Venous Leg Ulcer
Biological: HP802-247
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
440
May 2015
March 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01658618
802-247-09-030
Yes
Not Provided
Not Provided
Healthpoint
Healthpoint
Not Provided
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
Healthpoint
January 2014
To Top