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Leg UlcerPhase 3NCT00232973

Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers

A Phase 3 study testing ICXP007 in people with Leg Ulcer, run by Intercytex at 58 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leg Ulcer
What is being tested?
ICXP007
How many people
396 participants
Where
58 sitesin 3 countries
Study dates
Jul 2005to not given
Phase
Phase 3
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

  • Individuals who have a graft-ready venous leg ulcer of at least 3 months duration, which has not, responded to standard conventional therapy.
  • Individuals who have an Ankle Brachial Pressure Index (ABPI/ABI) of greater than or equal to 0.8 measured by Doppler sonography.
  • Individuals who have venous incompetency as defined by > 1.0 seconds in vein segments on standing reflux exam by duplex or an abnormal venous refill time of < 21 seconds by PPG or > 2 cc per second by APG. Duplex or PPG/APG will be used to establish venous insufficiency. Doppler will be utilized to rule out arterial disease.
  • Individuals who have a target wound which is between 2 cm2 to 20 cm2 in area at the screening assessment.
  • Individuals who are ambulatory.
  • Individuals who have voluntarily signed and dated a patient IRB/EC approved Informed Consent Form (ICF).
  • Individuals, who are, in the opinion of the Investigator, able to understand this study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.

Who cannot join

  • Individuals with a known hypersensitivity to Aprotinin or any other constituents of Tisseel VH S/DTM i.e. Fibrinogen (human), thrombin (human) and Calcium Chloride, Bovine and Porcine products.
  • Individuals who have a haemoglobin or serum albumin level which is < 10 g/dL or < 2.5 g/dL respectively, or is otherwise outside the normal range and deemed clinically significant.
  • Females who are pregnant, lactating, or who have not reached menopause and are not abstinent or practicing an acceptable means of birth control as determined by the Investigator for the duration of the study.
  • Individuals younger than 18 years of age.
  • Individuals with abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant.
  • Individuals who have exposed bone, tendon or fascia visible around the target wound.
Show all 17Show fewer
  • Individuals with evidence of collagen vascular diseases, such as vasculitis or rheumatoid arthritis, under active treatment.
  • Individuals with evidence of cellulitis or osteomyelitis during the previous 4 weeks.
  • Individuals who have a target wound which shows signs of clinical infection or who have a wound that has presence of ß-haemolytic streptococcus upon culture, or the Investigator suspects may be severely infected. Individuals may be enrolled upon eradication of the ß-haemolytic streptococcus infection/organism.
  • Individuals who have any clinically significant medical condition that would impair wound healing as determined by the Investigator, including uncontrolled diabetes as determined by HbA1C (>12%), or immune disease.
  • Individuals who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.
  • Individuals who have chronic renal insufficiency requiring haemodialysis.
  • Individuals who have received short course corticosteroids within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
  • Individuals who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.
  • Individuals who have participated in a clinical study of any investigational product within 2 months prior to treatment.
  • Individuals who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  • Individuals previously enrolled/randomized in this clinical trial.

Trial locations and contacts

58 sites in 3 countries.

58 sites in 3 countries

United States31 sites, 19 recruiting

  • Alameda County Medical Center

    Alameda, California, 94602

    Withdrawn

  • Dermatology, PLLC

    Ann Arbor, Michigan, 48103

    Active, not recruiting

  • Boston Medical Center, Department of Vascular Surgery

    Boston, Massachusetts, 02118

    Marina Malikova, 617-414-6836, marina@biochem.bumc.bu.edu

    Alik Faber, MD

    Recruiting

  • Manzainto Medical Clinic

    Carmichael, California, 95608

    Nadia Radchenko, 916-979-0621, nadyusharad@yahoo.com

    James Greenberg, MD

    Recruiting

  • Bay Area Foot Care

    Castro Valley, California, 94546

    Active, not recruiting

  • UNC Wound Care Clinic

    Chapel Hill, North Carolina, 27599

    Nicolle Lemire, 919-484-1437 ext. 278, nlemire@med.unc.edu

    William Marston, MD

    Recruiting

  • OSU Comprehensive Wound Center

    Columbus, Ohio, 43205

    Kathy Owen, 614-257-2414, kathy.owen@osumc.edu

    Lynn Lambert, 614 886 3690, lynn.lambert@osumc.edu

    Recruiting

  • OSU Comprehensive Wound Center

    Columbus, Ohio, 43221

    Kathy Owen, 614-257-2414, kathy.owen@osumc.edu

    Lynn Lambert, 614 886 3690, lynn.lambert@osumc.edu

    Recruiting

  • St Vincent Health Center

    Erie, Pennsylvania, 16544

    Cris Beuger, 814-452-7878, cbeuger@healingwounds.com

    Thomas Serena, MD

    Recruiting

  • M Limova, MD

    Fresno, California, 93711

    Active, not recruiting

  • University of Florida, Department of Surgery

    Gainesville, Florida, 32610

    Terminated

  • Armstrong County Memorial Hospital

    Kittanning, Pennsylvania, 16201

    Lisa Brumbaugh, 724-543-8536, brumbaughl@acmh.org

    Thomas Serena, MD

    Recruiting

  • Advanced Foot and Ankle Center

    Las Vegas, Nevada, 89119

    Joseph Dove, 702-696-9005, cyaandidove@msn.com

    Cyaandi Dove, MD

    Recruiting

  • Dr Francisco Kerdel

    Miami, Florida, 33136

    Active, not recruiting

  • Doctor's Research Network

    Miami, Florida, 33143

    Yvette Salamanca, 305-662-1444, jrhsbri@aol.com

    Jason Hanft

    Recruiting

  • Dermatology and Cosmetic Specialists

    Miramar, Florida, 33027

    Terminated

  • Institute for Advanced Wound Care

    Montgomery, Alabama, 36111

    Terminated

  • National Centre for Limb Preservation

    Niles, Illinois, 60714

    Julie Anderson, 847-723-3004, julie.anderson@advocatehealth.com

    Stephanie Wu, MD

    Recruiting

  • Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science

    North Chicago, Illinois, 60064

    Catherine Griffis, 210-464-4053, catherine.griffis@rosalindfranklin.edu

    David Armstrong, MD

    Recruiting

  • HOPE Research Institute

    Phoenix, Arizona, 85050

    Jason Haile, 602-288-4673, jason.haile@hriaz.com

    Arthur Tallis, MD

    Recruiting

  • Roger Williams Medical Centre

    Providence, Rhode Island, 02908

    Jaymie Panuncialman, 401-456-2203, jpanuncialman@rwmc.org

    Vincent Falanga, MD

    Recruiting

  • VA Medical Center

    Sacramento, California, 95655

    Active, not recruiting

  • Bay Area Foot care

    San Francisco, California, 94115

    Active, not recruiting

  • Prairie Vascular Institute

    Springfield, Illinois, 62702

    Mark Sanders, 217-544-6464 ext. 66072, msanders@prairierheart.com

    Raghu Kolluri

    Recruiting

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

    Billi Tatum, 253-968-2429, billi.tatum@us.arm.mil

    Charles Anderson

    Recruiting

  • Dr. Robert Snyder

    Tamarac, Florida, 33321

    Suzanne Wujceak, 954-721-4806, drwound@aol.com

    Robert Snyder, MD

    Recruiting

  • The Wound Healing Center

    Terre Haute, Indiana, 47807

    Terminated

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

    Katey Fahey, 718-920-5961, kfahey@montefiore.org

    Evan Lipsitz, MD

    Not yet recruiting

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

    Heather Kimbriel, 520-792-1450 ext. 6625

    Maureen Lifton, 520 792 1450 ext. 6625

    Recruiting

  • Penn North Centers for Advanced Wound Care

    Warren, Pennsylvania, 16365

    Cris Beuger, 814-688-5008, cbeuger@healingwounds.com

    Thomas Serena

    Recruiting

  • Central Washington Podiatry

    Yakima, Washington, 98902

    Active, not recruiting

Other trials in United States

United Kingdom17 sites, 14 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Rhoda MacKenzie, 01224 552281, rhodamackenzie@nhs.net

    Paul Bachoo

    Recruiting

  • Belfast City Hospital

    Belfast, BT9 1NR

    Gillian Swain, 02890 329 241 ext. 2038, gillian.swain@belfasttrust.hscni.net

    Louis Lau

    Not yet recruiting

  • Birmingham Heartlands Hospital, University Department of Vascular Surgery

    Birmingham, B9 5SS

    Emma Burke, emma.burke@heartofengland.nhs.uk

    Andrew Bradbury, BSc, MBChB, MD, FRCS Ed

    Recruiting

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

    Active, not recruiting

  • Cardiff University

    Cardiff, CF14 4XN

    Nicola Ivins, 029 20 746319, ivinsnm@Cardiff.ac.uk

    Keith Harding

    Recruiting

  • St Richards Hospital

    Chichester, PO19 6SE

    Hilary Ashton, 01243 831503, hilary.ashton@rws-tr.nhs.uk

    Hany Hafez

    Not yet recruiting

  • Russells Hall Hospital

    Dudley, DY1 2HQ

    Joy Lewis, 01384 456111, joy.lewis@dgoh.nhs.uk

    Sandy Shiralkar, MBBS, MS, FRCS, EBSQ

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

    Julie Stephens, 0845 422 6190, julie.stephens@glos.nhs.uk

    Jonathan Earnshaw

    Recruiting

  • Hull Royal Infirmary

    Hull, HU3 2JZ

    Josie Hatfield, +44 (0) 1482 674389, josie.hatfield@hey.nhs.uk

    Ian Chetter

    Recruiting

  • Vascular Surgical Unit, Leeds General Infirmary

    Leeds, LS1 3EX

    Terminated

  • St George's Hospital

    London, SW17 0QT

    Gill Horne, 0208 725 2877, gillian.horne@stgeorges.nhs.uk

    Ian Loftus

    Not yet recruiting

  • Department of Vascular Surgery, Manchester Royal Infirmary

    Manchester, Lancashire, M13 9WL

    Active, not recruiting

  • Derriford Hospital

    Plymouth, PL6 8HD

    Chryz Cosgrove, 01752 439226, chryz.cosgrove@phnt.swest.nhs.uk

    Alan Elstone, alan.elstone@phnt.swest.nhs.uk

    Recruiting

  • The Willows Centre for Health

    Salford, M5 5JR

    Silvia Stanway, 0161 212 4378, sylvia.stanway@salford-pct.nhs.uk

    John V Smyth

    Not yet recruiting

  • Clatterbridge Hospital, Surgical Outpatients

    Upton, Wirral, CH49 5PE

    Gwen Lawrence, gwen.lawrence@whnt.nhs.uk

    Stephen Blair, MS, FRCS

    Recruiting

  • Arrowe Park Hospital

    Upton, CH49 5PE

    Gwen Lawrence, 0151 678 5111 ext. 8362, gwen.lawrence@whnt.nhs.uk

    Stephen Blair, MS, FRCS

    Recruiting

  • Wrexham Maelor Hospital

    Wrexham, LL13 7TD

    Ruby Griffiths, 01978 725 124, ruby.griffiths@new-tr.wales.nhs.uk

    Tony Da Silva

    Recruiting

Other trials in United Kingdom

Canada10 sites, 4 recruiting

  • Western Canada Dermatology Institute

    Edmonton, Alberta, T5J 3S9

    Terminated

  • Eastern Canada Cutaneous Research Associates Ltd

    Halifax, Nova Scotia, B3H 1Z4

    Terminated

  • Centre Medical Ste-Dorothee

    Laval, Quebec, H7X 3S5

    Completed

  • Parkwood Hospital, St Joseph's Health Care

    London, Ontario, N6C 2J1

    Anne Lemesurier, RN, 519 685 4292 ext. 42163, anne.lemesurier@sjhc.london.on.ca

    David Keast, MD

    Recruiting

  • Gary Sibbald, MD

    Mississauga, Ontario, L4Y 1A6

    Completed

  • Entralogix

    Oakville, Ontario, L6K 1E1

    Vito Losito, 905-898-0716 ext. 206, vitolosito@entralogix.com

    Kristin Ingraham, 905 898 0716, kristiningraham@entralogix.com

    Recruiting

  • Dermatology Daycare

    Toronto, Ontario, M5S 1B2

    Completed

  • St Michael's Hospital

    Toronto, Ontario, M5W 1WB

    Tobi Mark, 416 864-6060 ext. 2162, markt@smh.toronto.on.ca

    James Mahoney

    Recruiting

  • Clinical Trials Unit, Skin Care Centre

    Vancouver, British Columbia, V5Z 4E8

    Completed

  • Entralogix

    Welland, Ontario, L0S 1C0

    Vito Losito, 905-898-0716 ext. 206, vitolosito@entralogix.com

    Kristin Ingraham, 905 898 0716, kristiningraham@entralogix.com

    Recruiting

Other trials in Canada

About this study

Official title: A Prospective, Multi-Centre, Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Safety and Efficacy of ICXP007 in a Phase III Trial With Four-Layer Therapeutic Compression, for the Treatment of Non-Infected Skin Leg Ulcers, Due to Venous-Insufficiency

The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.

Conditions
Leg Ulcer
Being tested
ICXP007
Medical subject headings
Leg Ulcer

What participants receive

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

  • ICXP007Drug

What is being measured

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

  1. Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Overall rate of wound area reduction during treatment.

  2. Time to first closure.

  3. Incidence of closure at 16, 20 and 24 weeks.

  4. Incidence of reopening at up to 16, 20 and 24 weeks.

  5. Incidence of re-closure at 16, 20 and 24 weeks.

  6. Qualitative levels of wound pain.

  7. Percentage of Day 0 wound surface area.

  8. Percentage reduction in wound surface area from previous visit.

  9. Percentage reduction in wound surface area from Day 0.

  10. Appearance of new ulcer in the target wound area post closure.

Timeline

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

  1. First posted5 Oct 2005 (estimated)
  2. Study startJul 2005

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
Double blind
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00232973
Sponsor's protocol ID
02-VLU-003
Status last verified
Feb 2008
First submitted
4 Oct 2005
Last updated
5 Feb 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ICXP007 in people with Leg Ulcer, run by Intercytex at 58 sites in 3 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 7 inclusion and 17 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 5 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, United Kingdom, 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. (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 NCT00232973.

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 5 Feb 2008.

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