Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
An Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)
1 other identifier
observational
221
5 countries
43
Brief Summary
This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). 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 802-247-09-032 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 802-247-09-032 Trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 22, 2017
June 1, 2017
1.5 years
October 22, 2013
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial.
The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the prior study.
Up to 12 months from first application of test article in the 802-247-09-032 study
Secondary Outcomes (1)
Follow-up on the status of the target ulcer as open, re-opened or closed.
Up to 12 months from first application of test article in the 802-247-09-032 study
Study Arms (2)
HP802-247 in prior study
Observational safety follow up study, no treatment specified
Vehicle Control in prior study
Observational safety follow up study, no treatment specified
Interventions
Eligibility Criteria
You may qualify if:
- The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
- Subject was randomized in 802-247-09-032 and received at least one application of test article.
- Subject has ended their participation in 802-247-09-032 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 for this study will be excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (43)
Unknown Facility
Brussels, Belgium
Unknown Facility
Edegem, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Brno, Czechia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Pardubice, Czechia
Unknown Facility
Plzen-Bory, Czechia
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Prague, Czechia
Unknown Facility
Třebíč, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Ústí nad Labem, Czechia
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Bochum, Germany
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Bonn, Germany
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Cologne, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Göttingen, Germany
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Greifswald, Germany
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Hamburg, Germany
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Kiel, Germany
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Krefeld, Germany
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Magdeburg, Germany
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München, Germany
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Münster, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Hatvan, Hungary
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Orosháza, Hungary
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Sátoraljaújhely, Hungary
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Szeged, Hungary
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Szolnok, Hungary
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Rzeszów, Poland
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Studzionka, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Zabrze, Poland
Biospecimen
The treatment assignment codes and randomization schedule for the prior trial will be maintained for this observational study. The treatment assignments will not be made known to the Investigators until the present follow-up study has been completed by all consenting subjects thus keeping treating physician and subjects blind to treatment.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Vanscheidt, MD
University Freiburg-Practice for Dermatology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 28, 2013
Study Start
May 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Publication submitted to Journal of Vascular Surgery in May 2017