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

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: Completed
• Conditions: Venous Leg Ulcer; Venous Stasis Ulcer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Closed Target Ulcers at Each Visit	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.	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

• Sponsor: Healthpoint
• Investigators: Study Director: Hebert B Slade, MD, FAAAAI, Healthpoint

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 11, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Leg Ulcer; VLU; Venous Leg Ulcer; Leg Wound; VSU; Venous Stasis Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 802-247-09-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO