Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
NCT ID: NCT01970657
Last Updated: 2017-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
221 participants
OBSERVATIONAL
2014-05-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
NCT01658618
Dose Finding Study of HP802-247 in Venous Leg Ulcers
NCT00852995
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
NCT01737762
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
NCT02154087
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
NCT01853384
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HP802-247 in prior study
Observational safety follow up study, no treatment specified
No treatment specified
No intervention
Vehicle Control in prior study
Observational safety follow up study, no treatment specified
No treatment
None specified
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No treatment specified
No intervention
No treatment
None specified
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Healthpoint
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wolfgang Vanscheidt, MD
Role: PRINCIPAL_INVESTIGATOR
University Freiburg-Practice for Dermatology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Plzen-Bory, , Czechia
Prague, , Czechia
Třebíč, , Czechia
Uherské Hradiště, , Czechia
Ústí nad Labem, , Czechia
Bochum, , Germany
Bonn, , Germany
Cologne, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Essen, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Greifswald, , Germany
Hamburg, , Germany
Kiel, , Germany
Krefeld, , Germany
Magdeburg, , Germany
München, , Germany
Münster, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Hatvan, , Hungary
Orosháza, , Hungary
Sátoraljaújhely, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Rzeszów, , Poland
Studzionka, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
802-247-09-033
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.