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

June 27, 2017 updated by: Healthpoint

A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C5J1
        • Aging Rehabilitation & Geriatric Care Research Center
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of AZ College of Medicine
    • California
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research
      • Encinitas, California, United States, 92024
        • ILD Consulting, Inc.
      • Los Angeles, California, United States, 90048
        • Vascular Surgery Associates
      • San Diego, California, United States, 92013
        • UCSD Wound Treatment and Research Center
    • Florida
      • Miami, Florida, United States, 33186
        • University of Miami
      • South Miami, Florida, United States, 33143
        • Doctors Research Network
      • Tamarac, Florida, United States, 33321
        • Robert J. Snyder
    • Illinois
      • Chicago, Illinois, United States, 60154
        • Northwestern University Feinberg School of Medicine
      • Jacksonville, Illinois, United States, 62650
        • Passavant Area Hospital
      • North Chicago, Illinois, United States, 60064
        • Rosalind Franklin University
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Wound Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Stoughton, Massachusetts, United States, 02972
        • New England Sinai Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advanced Foot and Ankle Center
    • New Jersey
      • Emerson, New Jersey, United States, 07630
        • Vincent Giacalone
      • New York, New Jersey, United States, 10025
        • St. Luke's Roosevelt Hospital Center
      • Summit, New Jersey, United States, 07901
        • Overglook Hospital Wound Healing Program
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17112
        • Harrisburg Foot and Ankle Center
      • Reading, Pennsylvania, United States, 19601
        • Center for Advanced Wound Care
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center
      • Dallas, Texas, United States, 75093
        • Wound Care Consultants
      • Lubbock, Texas, United States, 79410
        • Southwest Regional Wound Care Center
      • San Antonio, Texas, United States, 78205
        • Peripheral Vascular Associates
    • Utah
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center's Wound Clinic
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular, PLLC
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center Wound Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Over the 24-week study period, at each of the bi-monthly visits
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".
Over the 24-week study period, at each of the bi-monthly visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Healthpoint

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hebert B Slade, MD, FAAAAI, Healthpoint

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 802-247-09-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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