Venous Leg UlcerNCT00900029

Safety Follow-Up to HP 802-247-09-015

An observational study of Venous Leg Ulcer and Venous Stasis Ulcer, run by Healthpoint at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a 24-week observational follow safety study for Study 802-247-09-015. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Leg Ulcer, Venous Stasis Ulcer
What is being tested?: No HP802 Treatment
How many people: 206 participants
Where: 30 sitesin 2 countries
Study dates: Jun 2009to Jan 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.

Who may be able to join

Provide informed consent
Willing to comply with protocol instructions, including allowing all study assessments.
Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
Subject has ended their participation in HP 802-247-09-015 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

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

United States29 sites

Arlington Research Center
Arlington, Texas, 76011
Johns Hopkins Wound Center
Baltimore, Maryland, 21231
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
Boston Medical Center
Boston, Massachusetts, 02118
Center for Clinical Research
Castro Valley, California, 94546
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60154
Wound Care Consultants
Dallas, Texas, 75093
Vincent Giacalone
Emerson, New Jersey, 07630
ILD Consulting, Inc.
Encinitas, California, 92024
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, 17112
Passavant Area Hospital
Jacksonville, Illinois, 62650
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119
Vascular Surgery Associates
Los Angeles, California, 90048
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
University of Miami
Miami, Florida, 33186
St. Luke's Roosevelt Hospital Center
New York, New Jersey, 10025
Rosalind Franklin University
North Chicago, Illinois, 60064
Center for Advanced Wound Care
Reading, Pennsylvania, 19601
Peripheral Vascular Associates
San Antonio, Texas, 78205
UCSD Wound Treatment and Research Center
San Diego, California, 92013
Doctors Research Network
South Miami, Florida, 33143
Providence Sacred Heart Medical Center Wound Clinic
Spokane, Washington, 99204
Southern Illinois University
Springfield, Illinois, 62702
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, 84770
New England Sinai Hospital
Stoughton, Massachusetts, 02972
Overglook Hospital Wound Healing Program
Summit, New Jersey, 07901
Robert J. Snyder
Tamarac, Florida, 33321
University of AZ College of Medicine
Tucson, Arizona, 85724

Other trials in United States

Canada1 site

Aging Rehabilitation & Geriatric Care Research Center
London, Ontario, N6C5J1

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About this study

Official title: A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

This is a 24-week observational follow safety study for Study 802-247-09-015.

Read the detailed description

The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.

Conditions: Venous Leg Ulcer, Venous Stasis Ulcer
Being tested: No HP802 Treatment, No HP802 Vehicle Treatment
Keywords: Venous Leg Ulcer, Venous Stasis Ulcer, VLU, VSU, Leg Ulcer, Leg Wound
Medical subject headings: Varicose Ulcer, Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No HP802 TreatmentBiological
No HP802 Vehicle TreatmentOther

Study groups in NCT00900029
Study group	Role	What they receive
No HP802 Treatment		Treatment received in Study 802-247-09-015 was HP802 Receives: Biological: No HP802 Treatment
No HP802 Vehicle Treatment		Treatment received in Study 802-247-09-015 was HP802 Vehicle Receives: Other: No HP802 Vehicle Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants With Closed Target Ulcers at Each Visit
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Measured: Over the 24-week study period, at each of the bi-monthly visits
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
Measured: Over the 24-week study period, at each of the bi-monthly visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jan 2012

First posted12 May 2009 (estimated)
Study startJun 2009
Primary completionOct 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00900029
Sponsor's protocol ID: 802-247-09-016
Status last verified: Sep 2016
First submitted: 11 May 2009
Last updated: 2 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
ClinicalTrials.gov ID: NCT00900029
Acronym / sponsor ID: 802-247-09-016
Conditions: Venous Leg Ulcer, Venous Stasis Ulcer
Keywords: Venous Leg Ulcer, Venous Stasis Ulcer, VLU, VSU, Leg Ulcer, Leg Wound
Study type: Observational
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: HealthpointIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Oct 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 29 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a 24-week observational follow safety study for Study 802-247-09-015.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
No HP802 Treatment	–	Biological: No HP802 TreatmentTreatment received in Study 802-247-09-015 was HP802
No HP802 Vehicle Treatment	–	Other: No HP802 Vehicle TreatmentTreatment received in Study 802-247-09-015 was HP802 Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.

Key inclusion criteria (4 listed)

Provide informed consent
Willing to comply with protocol instructions, including allowing all study assessments.
Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
Subject has ended their participation in HP 802-247-09-015 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
No HP802 Treatment	Biological	No HP802 Treatment
No HP802 Vehicle Treatment	Other	No HP802 Vehicle Treatment

Primary outcome

The Number of Participants With Closed Target Ulcers at Each Visit
Time frame: Over the 24-week study period, at each of the bi-monthly visits
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
Time frame: Over the 24-week study period, at each of the bi-monthly visits
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".

Results and safety

Results posted to the registry on 29 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LD-Q14D	38	35
LD-Q7D	41	37
HD-Q14D	41	38
HD-Q7D	42	35
HP802-247 Vehicle	44	38

Primary outcome: The Number of Participants With Closed Target Ulcers at Each Visit

Time frame: Over the 24-week study period, at each of the bi-monthly visits. Number. Unit: participants

Measure	LD-Q14D n = 27	LD-Q7D n = 21	HD-Q14D n = 25	HD-Q7D n = 23	HP802-247 Vehicle n = 18
Enrollment	27	21	25	23	18
Month 2 (Visit 1)	22	19	24	20	17
Month 4 (Visit 2)	25	19	22	21	16
Month 6 (Visit 3)	25	19	21	20	15

Population analysed: Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.

Primary outcome: Number of Subjects With Target Wound Closed for the First Time During the Study Period.

Time frame: Over the 24-week study period, at each of the bi-monthly visits. Number. Unit: participants

Measure	LD-Q14D n = 8	LD-Q7D n = 16	HD-Q14D n = 13	HD-Q7D n = 12	HP802-247 Vehicle n = 20
Month 2 (Visit 1)	3	1	4	2	4
Month 4 (Visit 2)	5	3	4	5	8
Month 6 (Visit 3)	4	4	7	6	7

Population analysed: Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.

Adverse events

Time frame: The duration of the 24-week study period. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LD-Q14D	3 of 38 (7.9%)	10 of 38 (26.3%)	Not reported
LD-Q7D	0 of 41 (0%)	6 of 41 (14.6%)	Not reported
HD-Q14D	4 of 41 (9.8%)	5 of 41 (12.2%)	Not reported
HD-Q7D	5 of 42 (11.9%)	11 of 42 (26.2%)	Not reported
HP802-247 Vehicle	4 of 44 (9.1%)	14 of 44 (31.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
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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.

Hebert B Slade, MD, FAAAAI study director

Healthpoint

30 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 and Venous Stasis Ulcer, run by Healthpoint at 30 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 4 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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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?

Yes. Results are posted in the registry (first posted 29 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Participants With Closed Target Ulcers at Each Visit (time frame: Over the 24-week study period, at each of the bi-monthly visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900029.

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 2 Aug 2017.