Clinical trial NCT01970657: Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Leg Ulcer (VLU)
Keywords: Venous Stasis Ulcer
VLU
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subjects who refuse to provide written informed consent for this study will be excluded from this study.

Primary outcomes:
measure: 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.
timeFrame: Up to 12 months from first application of test article in the 802-247-09-032 study
Secondary outcomes:
measure: Follow-up on the status of the target ulcer as open, re-opened or closed.
timeFrame: Up to 12 months from first application of test article in the 802-247-09-032 study
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Olomouc
country: Czechia
city: Pardubice
country: Czechia
city: Plzen-Bory
country: Czechia
city: Praha
country: Czechia
city: Trebic
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Usti nad Labem
country: Czechia
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Duesseldorf
country: Germany
city: Essen
country: Germany
city: Freiburg
country: Germany
city: Goettingen
country: Germany
city: Greifswald
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Koeln
country: Germany
city: Krefeld
country: Germany
city: Magdeburg
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Hatvan
country: Hungary
city: Oroshaza
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szeged
country: Hungary
city: Szolnok
country: Hungary
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Rzeszow
country: Poland
city: Studzionka
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
Study officials:
affiliation: University Freiburg-Practice for Dermatology
name: Wolfgang Vanscheidt, MD
role: PRINCIPAL_INVESTIGATOR
References: