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
  Purpose

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.


Condition
Venous Leg Ulcer
Venous Stasis Ulcer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 206
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Safety Follow-Up to HP 802-247-09-015

  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

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.

Criteria

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.
  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: NCT00900029

  Show 30 Study Locations
Sponsors and Collaborators
Healthpoint
Investigators
Study Director: Hebert B Slade, MD, FAAAAI Healthpoint
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00900029     History of Changes
Other Study ID Numbers: 802-247-09-016
Study First Received: May 11, 2009
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
Venous Leg Ulcer
Venous Stasis Ulcer
VLU
VSU
Leg Ulcer
Leg Wound

Additional relevant MeSH terms:
Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014