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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900029
First Posted: May 12, 2009
Last Update Posted: August 2, 2017
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
  Purpose
This is a 24-week observational follow safety study for Study 802-247-09-015.

Condition Intervention
Venous Leg Ulcer Venous Stasis Ulcer Biological: No HP802 Treatment Other: No HP802 Vehicle Treatment

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

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • The Number of Participants With Closed Target Ulcers at Each Visit [ Time Frame: Over the 24-week study period, at each of the bi-monthly visits ]
    At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.

  • Number of Subjects With Target Wound Closed for the First Time During the Study Period. [ Time Frame: Over the 24-week study period, at each of the bi-monthly visits ]
    At each visit the status of open target ulcers was evaluated as "remained open" or "closed".


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 Assigned Interventions
No HP802 Treatment
Treatment received in Study 802-247-09-015 was HP802
Biological: No HP802 Treatment
No HP802 Vehicle Treatment
Treatment received in Study 802-247-09-015 was HP802 Vehicle
Other: No HP802 Vehicle Treatment

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900029


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

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00900029     History of Changes
Other Study ID Numbers: 802-247-09-016
First Submitted: May 11, 2009
First Posted: May 12, 2009
Results First Submitted: September 28, 2016
Results First Posted: September 29, 2016
Last Update Posted: August 2, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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