Venous Leg Ulcer (VLU)NCT01970657
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
An observational study of Venous Leg Ulcer (VLU), run by Healthpoint at 43 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- No treatment specified and No treatment
- How many people
- 221 participants
- Where
- 43 sitesin 5 countries
- Study dates
- May 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects who refuse to provide written informed consent for this study will be excluded from this study.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
Germany15 sites
Study site
Bochum
Study site
Bonn
Study site
Cologne
Study site
Dresden
Study site
Düsseldorf
Study site
Essen
Study site
Freiburg im Breisgau
Study site
Göttingen
Study site
Greifswald
Study site
Hamburg
Study site
Kiel
Study site
Krefeld
Study site
Magdeburg
Study site
München
Study site
Münster
Czechia9 sites
Study site
Brno
Study site
Hradec Králové
Study site
Olomouc
Study site
Pardubice
Study site
Plzen-Bory
Study site
Prague
Study site
Třebíč
Study site
Uherské Hradiště
Study site
Ústí nad Labem
Poland9 sites
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Rzeszów
Study site
Studzionka
Study site
Warsaw
Study site
Wroclaw
Study site
Zabrze
Hungary7 sites
Study site
Budapest
Study site
Debrecen
Study site
Hatvan
Study site
Orosháza
Study site
Sátoraljaújhely
Study site
Szeged
Study site
Szolnok
About this study
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)
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:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
- to record wound status, and
- 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.
Read the 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.
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- No treatment specified, No treatment
- Keywords
- Venous Stasis Ulcer, VLU
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment specifiedBiological
No intervention
No treatmentBiological
None specified
| Study group | Role | What they receive |
|---|---|---|
| HP802-247 in prior study | Observational safety follow up study, no treatment specified Receives: Biological: No treatment specified | |
| Vehicle Control in prior study | Observational safety follow up study, no treatment specified Receives: Biological: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
At each study visit the status of the target ulcer was assessed as remaining closed, re-opened, or a new closure.
Measured: Up to 12 months from first application of test article in the 802-247-09-032 study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Vanscheidt, MD, Principal investigator, University Freiburg-Practice for Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970657
- Sponsor's protocol ID
- 802-247-09-033
- Status last verified
- Jun 2017
- First submitted
- 22 Oct 2013
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication submitted to Journal of Vascular Surgery in May 2017
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01970657
- Acronym / sponsor ID
- 802-247-09-033
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- Venous Stasis Ulcer, VLU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
- to record wound status, and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP802-247 in prior study | – | Biological: No treatment specifiedObservational safety follow up study, no treatment specified |
| Vehicle Control in prior study | – | Biological: No treatmentObservational safety follow up study, no treatment specified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who refuse to provide written informed consent for this study will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment specifiedNo intervention | Biological | HP802-247 in prior study |
| No treatmentNone specified | Biological | Vehicle Control in prior study |
Primary outcome
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.
Time frame: Up to 12 months from first application of test article in the 802-247-09-032 study
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.
1 secondary outcome
Follow-up on the status of the target ulcer as open, re-opened or closed.
Time frame: Up to 12 months from first application of test article in the 802-247-09-032 study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: Yes. Publication submitted to Journal of Vascular Surgery in May 2017
Related trials for Venous Leg Ulcer (VLU)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Vanscheidt, MD principal investigator
University Freiburg-Practice for Dermatology
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer (VLU), run by Healthpoint at 43 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany, Czechia, Poland, Hungary, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 12 months from first application of test article in the 802-247-09-032 study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.