Venous Leg UlcerNCT01658618
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
An observational study of Venous Leg Ulcer, run by Healthpoint at 49 sites in 2 countries.
Trial summary
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- HP802-247
- How many people
- 440 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Sep 2012to May 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
Study population: The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.
Who may be able to join
- Provide informed consent document
- Subject was randomized in 802-247-09-029 and received at least one application of a test article.
- Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.
Who cannot join
- Subjects who refuse to provide written informed consent will be excluded from this trial.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States44 sites
Study site
Akron, Ohio, 44307
Study site
Baltimore, Maryland, 21224
Study site
Boston, Massachusetts, 02118
Study site
Cambridge, Massachusetts, 02138
Study site
Carlsbad, California, 92009
Study site
Castro Valley, California, 94546
Study site
Chapel Hill, North Carolina, 27599
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60616
Study site
Dallas, Texas, 75390
Study site
Dunmore, Pennsylvania, 18512
Study site
Emerson, New Jersey, 07630
Study site
Fort Worth, Texas, 76104
Study site
Fort Worth, Texas, 76107
Study site
Gainesville, Florida, 32605
Study site
Glendale, Arizona, 85306
Study site
Hialeah, Florida, 33013
Study site
Jacksonville, Illinois, 62650
Study site
Laguna Hills, California, 92653
Study site
Las Vegas, Nevada, 89119
Study site
Long Beach, California, 90822
Study site
Los Angeles, California, 90095
Study site
Miami, Florida, 33125
Study site
New York, New York, 10025
Study site
North Chicago, Illinois, 60064
Study site
Phoenix, Arizona, 85006
Study site
Phoenix, Arizona, 85012
Study site
Roanoke, Virginia, 24013
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92013
Study site
San Francisco, California, 94115
Study site
South Miami, Florida, 33143
Study site
Springfield, Illinois, 62702
Study site
St. George, Utah, 84770
Study site
Stockton, California, 95204
Study site
Sylmar, California, 91342
Study site
Tacoma, Washington, 98431
Study site
Tamarac, Florida, 33321
Study site
Tucson, Arizona, 85723
Study site
Tucson, Arizona, 85724
Study site
Tulsa, Oklahoma, 74127
Study site
Washington D.C., District of Columbia, 20007
Study site
Wyomissing, Pennsylvania, 19610
Canada5 sites
Study site
Greater Sudbury, Ontario, P3E5J1
Study site
Hamilton, Ontario, L8R2R3
Study site
London, Ontario, N6C5J1
Study site
Sherbrooke, Quebec, J1H5N4
Study site
Vancouver, British Columbia, V5Z1M9
About this study
Official title: A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). 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 802-247-09-029 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 802-247-09-029 Trial.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
- Conditions
- Venous Leg Ulcer
- Being tested
- HP802-247
- Keywords
- Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu, hp802-247-09-029
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP802-247Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.
Measured: 12 months
Secondary outcomes (1)
Exploratory Objectives
The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Chief Medical OfficerTommy Lee, MSHS, Study director, Associate Director Clinical OperationsRobert Kirsner, MD, Principal investigator, InvestigatorWilliam Marston, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658618
- Sponsor's protocol ID
- 802-247-09-030
- Status last verified
- Jan 2014
- First submitted
- 1 Aug 2012
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
- ClinicalTrials.gov ID
- NCT01658618
- Acronym / sponsor ID
- 802-247-09-030
- Conditions
- Venous Leg Ulcer
- Keywords
- Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu, hp802-247-09-029
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 7 Aug 2012 (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 observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). 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 802-247-09-029 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 802-247-09-029 Trial.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.
Key inclusion criteria (3 listed)
- Provide informed consent document
- Subject was randomized in 802-247-09-029 and received at least one application of a test article.
- Subject has ended their participation in 802-247-09-029 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 will be excluded from this trial.
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 |
|---|---|---|
| HP802-247 | Biological | – |
Primary outcome
Primary Objective
Time frame: 12 months
The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.
1 secondary outcome
Exploratory Objectives
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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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.
Herbert B Slade, MD study chair
Chief Medical Officer
Tommy Lee, MSHS study director
Associate Director Clinical Operations
Robert Kirsner, MD principal investigator
Investigator
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer, run by Healthpoint at 49 sites in 2 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: status not confirmed, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. 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?
Results are not available in the source record.
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?
Primary Objective (time frame: 12 months). 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 3 Feb 2014.