Venous Leg UlcerPhase 2NCT00852995

Dose Finding Study of HP802-247 in Venous Leg Ulcers

A Phase 2 study testing HP802-247 in people with Venous Leg Ulcer and Venous Stasis Ulcers, 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 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Leg Ulcer, Venous Stasis Ulcers
What is being tested?: HP802-247
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 30 sitesin 2 countries
Study dates: Feb 2009to Jul 2011
Phase: Phase 2
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

Who may be able to join

Provide informed consent.
Willing to comply with protocol instructions, including allowing all study assessments.
Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Who cannot join

Women who are pregnant or lactating
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.

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, LLC
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
Overlook 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

Other trials in Canada

About this study

Official title: A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

Conditions: Venous Leg Ulcer, Venous Stasis Ulcers
Being tested: HP802-247, Placebo (Vehicle)
Keywords: Venous Leg Ulcer (VLU), Venous Stasis Ulcer (VSU), 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.

HP802-247Biological
One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Placebo (Vehicle)Biological
Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Study groups in NCT00852995
Study group	Role	What they receive
A - Low Q7D	Experimental	Low dose HP802-247, applied at each visit Receives: Biological: HP802-247
B - Low Q14D	Experimental	Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12 Receives: Biological: HP802-247
C - High Q7D	Experimental	High dose HP802-247, applied at each visit Receives: Biological: HP802-247
D - High Q14D	Experimental	High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12 Receives: Biological: HP802-247
E - Vehicle	Placebo comparator	Placebo (Vehicle), applied at each visit Receives: Biological: Placebo (Vehicle)

What is being measured

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

The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Measured: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

Secondary outcomes (6)

Kaplan-Meier Probability of Non-Closure
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Measured: 14 weeks - the final visit for one subject was delayed by two weeks
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Measured: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Measured: Over the 12 week treatment period or until the wound closed, which ever occurred first.
Percentage of Participants With Complete Wound Closure at Each Visit
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Measured: Weekly, over the 12 week treatment period
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Measured: Weekly, over the 12 week treatment period
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Measured: 14 weeks - the final visit for one subject was delayed by two weeks

Timeline

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

Feb 2009Jul 2011

First posted27 Feb 2009 (estimated)
Study startFeb 2009
Primary completionApr 2011
Study completionJul 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00852995
Sponsor's protocol ID: 802-247-09-015
Status last verified: Sep 2016
First submitted: 26 Feb 2009
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.
PubMed 22863328

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 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
ClinicalTrials.gov ID: NCT00852995
Acronym / sponsor ID: 802-247-09-015
Conditions: Venous Leg Ulcer, Venous Stasis Ulcers
Keywords: Venous Leg Ulcer (VLU), Venous Stasis Ulcer (VSU), VLU, VSU, Leg Ulcer, Leg Wound
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: HealthpointIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Apr 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 27 Feb 2009 (estimated)
Results: Posted 14 Mar 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
A - Low Q7D	Experimental	Biological: HP802-247Low dose HP802-247, applied at each visit
B - Low Q14D	Experimental	Biological: HP802-247Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
C - High Q7D	Experimental	Biological: HP802-247High dose HP802-247, applied at each visit
D - High Q14D	Experimental	Biological: HP802-247High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
E - Vehicle	Placebo comparator	Biological: Placebo (Vehicle)Placebo (Vehicle), applied at each visit

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provide informed consent.
Willing to comply with protocol instructions, including allowing all study assessments.
Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Key exclusion criteria (6 listed)

Women who are pregnant or lactating
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.

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
HP802-247One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.	Biological	A - Low Q7D, B - Low Q14D, C - High Q7D, D - High Q14D
Placebo (Vehicle)Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution	Biological	E - Vehicle

Primary outcome

The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.

6 secondary outcomes

Kaplan-Meier Probability of Non-Closure
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Time frame: Over the 12 week treatment period or until the wound closed, which ever occurred first.
Percentage of Participants With Complete Wound Closure at Each Visit
Time frame: Weekly, over the 12 week treatment period
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Time frame: Weekly, over the 12 week treatment period
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks

Results and safety

Results posted to the registry on 14 Mar 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
B - Low Q14D	46	38
A - Low Q7D	43	42
D - High Q14D	44	39
C - High Q7D	45	40
E - HP802-247 Vehicle	50	46

Primary outcome: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.

Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first. Mean (Standard Deviation). Unit: percent change

Measure	B - Low Q14D n = 46	A - Low Q7D n = 43	D - High Q14D n = 44	C - High Q7D n = 45	E - HP802-247 Vehicle n = 50
Value	-77.11 (21.95)	-70.15 (21.66)	-68.14 (26.29)	-72.89 (27.27)	-60.38 (29.79)

B - Low Q14D vs E - HP802-247 Vehicle: p = 0.00028, t-test, 2 sided
A - Low Q7D vs E - HP802-247 Vehicle: p = 0.0899, t-test, 2 sided
D - High Q14D vs E - HP802-247 Vehicle: p = 0.1586, t-test, 2 sided

Population analysed: ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P \< 0.05.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The duration of the 12-week treatment period. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E - HP802-247 Vehicle	4 of 50 (8%)	26 of 50 (52%)	Not reported
B - Low Q14D	4 of 46 (8.7%)	15 of 46 (32.6%)	Not reported
A - Low Q7D	3 of 43 (7%)	19 of 43 (44.2%)	Not reported
D - High Q14D	3 of 43 (7%)	16 of 44 (36.4%)	Not reported
C - High Q7D	2 of 45 (4.4%)	17 of 45 (37.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22863328Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.

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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

Healthpoint

William Marston, MD principal investigator

University of North Carolina

Robert Kirsner, MD principal investigator

University of Miami

30 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HP802-247 in people with Venous Leg Ulcer and Venous Stasis Ulcers, 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 5 inclusion and 6 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 24 Oct 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 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 Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. (time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first). 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 NCT00852995, which also lists 1 linked publication.

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 24 Oct 2016.