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Venous Leg UlcersPhase 3NCT01656889

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

A Phase 3 study testing HP-802-247 in people with Venous Leg Ulcers, run by Healthpoint at 50 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 study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcers
What is being tested?
HP-802-247
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
447 participants
Where
50 sitesin 2 countries
Study dates
Aug 2012to Dec 2014
Phase
Phase 3
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.
  • Age ≥ 18 years and of either sex.
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
  • Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
  • Arterial supply adequacy confirmed
Show all 9Show fewer
  • Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
  • Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
  • Acceptable state of health and nutrition

Who cannot join

  • History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
  • Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
  • Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
  • A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
  • Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
  • Refusal of or inability to tolerate compression therapy.
Show all 9Show fewer
  • Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
  • History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
  • Any prior exposure to HP802-247 or its vehicle.

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States45 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

    Fresno, California, 93720

  • 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

Other trials in United States

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

    Vancovuer, British Columbia, V5Z1M9

Other trials in Canada

About this study

Official title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

Being tested
HP-802-247, Vehicle
Keywords
Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu
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.

  • HP-802-247Biological

    HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.

  • VehicleBiological

    (fibrinogen solution \& thrombin solution without cells)

Study groups in NCT01656889
Study groupRoleWhat they receive
HP802-247ExperimentalHP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Receives: Biological: HP-802-247
VehiclePlacebo comparatorVehicle Control (fibrinogen solution \& thrombin solution without cells)
Receives: Biological: Vehicle

What is being measured

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

  1. Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

    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. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

    Measured: 12 Weeks

Secondary outcomes (6)

  1. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.

    Measured: 12 Weeks

  2. Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline

    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, or until wound closure, which ever occurred first

  3. Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

    Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.

    Measured: Target ulcer status observed at two and three months following initial ulcer closure.

  4. Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

    Target leg pain were 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.

    Measured: Weekly, over the 12 week treatment period, baseline

  5. Change in Target Ulcer Pain

    Target ulcer pain were 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.

    Measured: Weekly, over 12 week treament period, baseline

  6. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Kaplan-Meier survival analysis.

    Measured: 12 weeks

Timeline

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

  1. First posted3 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01656889
Sponsor's protocol ID
802-247-09-029
Status last verified
Feb 2016
First submitted
1 Aug 2012
Last updated
14 Mar 2016
Data monitoring committee
Yes

Publications

  • Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.

    PubMed 29037354

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HP-802-247 in people with Venous Leg Ulcers, run by Healthpoint at 50 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 9 inclusion and 9 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (time frame: 12 Weeks). 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 NCT01656889, 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 14 Mar 2016.

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