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

NCT ID: NCT00900029

Last Updated: 2017-08-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Venous Leg Ulcer Venous Stasis Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No HP802 Treatment

Treatment received in Study 802-247-09-015 was HP802

No HP802 Treatment

Intervention Type BIOLOGICAL

No HP802 Vehicle Treatment

Treatment received in Study 802-247-09-015 was HP802 Vehicle

No HP802 Vehicle Treatment

Intervention Type OTHER

Interventions

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No HP802 Treatment

Intervention Type BIOLOGICAL

No HP802 Vehicle Treatment

Intervention Type OTHER

Eligibility Criteria

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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.
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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Hebert B Slade, MD, FAAAAI

Role: STUDY_DIRECTOR

Healthpoint

Locations

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University of AZ College of Medicine

Tucson, Arizona, United States

Site Status

Center for Clinical Research

Castro Valley, California, United States

Site Status

ILD Consulting, Inc.

Encinitas, California, United States

Site Status

Vascular Surgery Associates

Los Angeles, California, United States

Site Status

UCSD Wound Treatment and Research Center

San Diego, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Doctors Research Network

South Miami, Florida, United States

Site Status

Robert J. Snyder

Tamarac, Florida, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Passavant Area Hospital

Jacksonville, Illinois, United States

Site Status

Rosalind Franklin University

North Chicago, Illinois, United States

Site Status

Southern Illinois University

Springfield, Illinois, United States

Site Status

Johns Hopkins Wound Center

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

New England Sinai Hospital

Stoughton, Massachusetts, United States

Site Status

Advanced Foot and Ankle Center

Las Vegas, Nevada, United States

Site Status

Vincent Giacalone

Emerson, New Jersey, United States

Site Status

St. Luke's Roosevelt Hospital Center

New York, New Jersey, United States

Site Status

Overglook Hospital Wound Healing Program

Summit, New Jersey, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Harrisburg Foot and Ankle Center

Harrisburg, Pennsylvania, United States

Site Status

Center for Advanced Wound Care

Reading, Pennsylvania, United States

Site Status

Arlington Research Center

Arlington, Texas, United States

Site Status

Wound Care Consultants

Dallas, Texas, United States

Site Status

Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Peripheral Vascular Associates

San Antonio, Texas, United States

Site Status

Dixie Regional Medical Center's Wound Clinic

St. George, Utah, United States

Site Status

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Site Status

Providence Sacred Heart Medical Center Wound Clinic

Spokane, Washington, United States

Site Status

Aging Rehabilitation & Geriatric Care Research Center

London, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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802-247-09-016

Identifier Type: -

Identifier Source: org_study_id

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