Text Size

Safety Follow-Up to HP 802-247-09-015

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT00900029
First received: May 11, 2009
Last updated: January 5, 2012
Last verified: January 2012
History of Changes

May 11, 2009
January 5, 2012
June 2009
October 2011   (final data collection date for primary outcome measure)
  • Complete wound closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Durability of previous target wound closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900029 on ClinicalTrials.gov Archive Site
  • Identify new test article-related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Record new target wound closures [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Follow-Up to HP 802-247-09-015
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.
  • Venous Leg Ulcer
  • Venous Stasis Ulcer
Not Provided
1
Safety Follow-Up to HP 802-247-09-015
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
January 2012
October 2011   (final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Provide informed consent
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
  • Subject has ended their participation in HP 802-247-09-015 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00900029
802-247-09-016
No
Healthpoint
Healthpoint
Not Provided
Study Director: Hebert B Slade, MD, FAAAAI Healthpoint
Healthpoint
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP