An observational study in Venous Leg Ulcer (VLU), sponsored by Healthpoint. Completed at 43 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-22.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Observational
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:
About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.
Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 221 is above the median of 131 across 47 observational studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Healthpoint is the lead sponsor of 34 studies on the registry; none are open to participants now.
First submitted after Healthpoint became part of Smith & Nephew, Inc..
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational safety follow up study, no treatment specified
Biological: No treatment specified
Observational safety follow up study, no treatment specified
Biological: No treatment
No intervention
None specified
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.
Time frame: Up to 12 months from first application of test article in the 802-247-09-032 study
Follow-up on the status of the target ulcer as open, re-opened or closed.
At each study visit the status of the target ulcer was assessed as remaining closed, re-opened, or a new closure.
Time frame: Up to 12 months from first application of test article in the 802-247-09-032 study
Plan to share: Yes — Publication submitted to Journal of Vascular Surgery in May 2017
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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