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

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.
 
ClinicalTrials.gov Identifier: NCT00900029
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : September 29, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Description
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Brief Summary:
This is a 24-week observational follow safety study for Study 802-247-09-015.

Condition or disease Intervention/treatment
Venous Leg Ulcer Venous Stasis Ulcer Biological: No HP802 Treatment 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.
Study Design
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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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".


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Healthpoint
Investigators
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Study Director: Hebert B Slade, MD, FAAAAI Healthpoint
More Information
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Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00900029    
Other Study ID Numbers: 802-247-09-016
First Posted: May 12, 2009    Key Record Dates
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:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases