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

NCT ID: NCT01658618

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HP802-247

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healthpoint

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herbert B Slade, MD

Role: STUDY_CHAIR

Chief Medical Officer

Tommy Lee, MSHS

Role: STUDY_DIRECTOR

Associate Director Clinical Operations

Robert Kirsner, MD

Role: PRINCIPAL_INVESTIGATOR

Investigator

William Marston, MD

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Carlsbad, California, United States

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Castro Valley, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Stockton, California, United States

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Sylmar, California, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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Tamarac, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Jacksonville, Illinois, United States

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North Chicago, Illinois, United States

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Springfield, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Las Vegas, Nevada, United States

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Emerson, New Jersey, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Akron, Ohio, United States

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Tulsa, Oklahoma, United States

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Dunmore, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Roanoke, Virginia, United States

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Tacoma, Washington, United States

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Vancouver, British Columbia, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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802-247-09-030

Identifier Type: -

Identifier Source: org_study_id

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