Safety Follow-Up to HP 802-247-09-015
A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
1 other identifier
observational
206
2 countries
30
Brief Summary
This is a 24-week observational follow safety study for Study 802-247-09-015.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
September 29, 2016
CompletedAugust 2, 2017
September 1, 2016
2.3 years
May 11, 2009
September 28, 2016
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
No HP802 Treatment
Treatment received in Study 802-247-09-015 was HP802
No HP802 Vehicle Treatment
Treatment received in Study 802-247-09-015 was HP802 Vehicle
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Subjects who refuse to provide written informed consent will be excluded from this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (30)
University of AZ College of Medicine
Tucson, Arizona, 85724, United States
Center for Clinical Research
Castro Valley, California, 94546, United States
ILD Consulting, Inc.
Encinitas, California, 92024, United States
Vascular Surgery Associates
Los Angeles, California, 90048, United States
UCSD Wound Treatment and Research Center
San Diego, California, 92013, United States
University of Miami
Miami, Florida, 33186, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Robert J. Snyder
Tamarac, Florida, 33321, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60154, United States
Passavant Area Hospital
Jacksonville, Illinois, 62650, United States
Rosalind Franklin University
North Chicago, Illinois, 60064, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Johns Hopkins Wound Center
Baltimore, Maryland, 21231, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
New England Sinai Hospital
Stoughton, Massachusetts, 02972, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119, United States
Vincent Giacalone
Emerson, New Jersey, 07630, United States
St. Luke's Roosevelt Hospital Center
New York, New Jersey, 10025, United States
Overglook Hospital Wound Healing Program
Summit, New Jersey, 07901, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, 17112, United States
Center for Advanced Wound Care
Reading, Pennsylvania, 19601, United States
Arlington Research Center
Arlington, Texas, 76011, United States
Wound Care Consultants
Dallas, Texas, 75093, United States
Southwest Regional Wound Care Center
Lubbock, Texas, 79410, United States
Peripheral Vascular Associates
San Antonio, Texas, 78205, United States
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, 84770, United States
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004, United States
Providence Sacred Heart Medical Center Wound Clinic
Spokane, Washington, 99204, United States
Aging Rehabilitation & Geriatric Care Research Center
London, Ontario, N6C5J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jaime E Dickerson, PhD
- Organization
- Smith & Nephew, Inc.
Study Officials
- STUDY DIRECTOR
Hebert B Slade, MD, FAAAAI
Healthpoint
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 12, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
January 1, 2012
Last Updated
August 2, 2017
Results First Posted
September 29, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share