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

February 4, 2008 updated by: Intercytex

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Terminated
        • Western Canada Dermatology Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Completed
        • Clinical Trials Unit, Skin Care Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
        • Terminated
        • Eastern Canada Cutaneous Research Associates Ltd
    • Ontario
      • London, Ontario, Canada, N6C 2J1
        • Recruiting
        • Parkwood Hospital, St Joseph's Health Care
        • Contact:
        • Principal Investigator:
          • David Keast, MD
      • Mississauga, Ontario, Canada, L4Y 1A6
        • Completed
        • Gary Sibbald, MD
      • Oakville, Ontario, Canada, L6K 1E1
      • Toronto, Ontario, Canada, M5S 1B2
        • Completed
        • Dermatology Daycare
      • Toronto, Ontario, Canada, M5W 1WB
        • Recruiting
        • St Michael's Hospital
        • Contact:
        • Principal Investigator:
          • James Mahoney
      • Welland, Ontario, Canada, L0S 1C0
    • Quebec
      • Laval, Quebec, Canada, H7X 3S5
        • Completed
        • Centre Medical Ste-Dorothee
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Paul Bachoo
      • Belfast, United Kingdom, BT9 1NR
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • Birmingham Heartlands Hospital, University Department of Vascular Surgery
        • Contact:
        • Principal Investigator:
          • Andrew Bradbury, BSc, MBChB, MD, FRCS Ed
      • Bradford, United Kingdom, BD9 6RJ
        • Active, not recruiting
        • Bradford Royal Infirmary
      • Cardiff, United Kingdom, CF14 4XN
        • Recruiting
        • Cardiff University
        • Contact:
        • Principal Investigator:
          • Keith Harding
      • Chichester, United Kingdom, PO19 6SE
        • Not yet recruiting
        • St Richards Hospital
        • Contact:
        • Principal Investigator:
          • Hany Hafez
      • Dudley, United Kingdom, DY1 2HQ
        • Recruiting
        • Russells Hall Hospital
        • Contact:
        • Principal Investigator:
          • Sandy Shiralkar, MBBS, MS, FRCS, EBSQ
      • Gloucester, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucestershire Royal Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan Earnshaw
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • Hull Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Ian Chetter
      • Leeds, United Kingdom, LS1 3EX
        • Terminated
        • Vascular Surgical Unit, Leeds General Infirmary
      • London, United Kingdom, SW17 0QT
        • Not yet recruiting
        • St George's Hospital
        • Contact:
        • Principal Investigator:
          • Ian Loftus
      • Plymouth, United Kingdom, PL6 8HD
      • Salford, United Kingdom, M5 5JR
        • Not yet recruiting
        • The Willows Centre for Health
        • Contact:
        • Principal Investigator:
          • John V Smyth
      • Upton, United Kingdom, CH49 5PE
        • Recruiting
        • Arrowe Park Hospital
        • Principal Investigator:
          • Stephen Blair, MS, FRCS
        • Contact:
      • Wrexham, United Kingdom, LL13 7TD
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Active, not recruiting
        • Department of Vascular Surgery, Manchester Royal Infirmary
    • Wirral
      • Upton, Wirral, United Kingdom, CH49 5PE
        • Recruiting
        • Clatterbridge Hospital, Surgical Outpatients
        • Contact:
        • Principal Investigator:
          • Stephen Blair, MS, FRCS
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Terminated
        • Institute for Advanced Wound Care
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Recruiting
        • Hope Research Institute
        • Contact:
        • Principal Investigator:
          • Arthur Tallis, MD
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System
        • Contact:
          • Heather Kimbriel
          • Phone Number: 6625 520-792-1450
        • Contact:
          • Maureen Lifton
          • Phone Number: 6625 520 792 1450
        • Principal Investigator:
          • Jodi Walters, MD
    • California
      • Alameda, California, United States, 94602
        • Withdrawn
        • Alameda County Medical Center
      • Carmichael, California, United States, 95608
        • Recruiting
        • Manzainto Medical Clinic
        • Contact:
        • Principal Investigator:
          • James Greenberg, MD
        • Sub-Investigator:
          • Pavel Polskiy, MD
      • Castro Valley, California, United States, 94546
        • Active, not recruiting
        • Bay Area Foot Care
      • Fresno, California, United States, 93711
        • Active, not recruiting
        • M Limova, MD
      • Sacramento, California, United States, 95655
        • Active, not recruiting
        • VA Medical Center
      • San Francisco, California, United States, 94115
        • Active, not recruiting
        • Bay Area Foot Care
    • Florida
      • Gainesville, Florida, United States, 32610
        • Terminated
        • University of Florida, Department of Surgery
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • Dr Francisco Kerdel
      • Miami, Florida, United States, 33143
        • Recruiting
        • Doctor's Research Network
        • Contact:
        • Principal Investigator:
          • Jason Hanft
      • Miramar, Florida, United States, 33027
        • Terminated
        • Dermatology and Cosmetic Specialists
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Dr. Robert Snyder
        • Contact:
        • Principal Investigator:
          • Robert Snyder, MD
    • Illinois
      • Niles, Illinois, United States, 60714
        • Recruiting
        • National Centre for Limb Preservation
        • Contact:
        • Principal Investigator:
          • Stephanie Wu, MD
      • North Chicago, Illinois, United States, 60064
        • Recruiting
        • Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science
        • Contact:
        • Principal Investigator:
          • David Armstrong, MD
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Prairie Vascular Institute
        • Contact:
        • Principal Investigator:
          • Raghu Kolluri
    • Indiana
      • Terre Haute, Indiana, United States, 47807
        • Terminated
        • The Wound Healing Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center, Department of Vascular Surgery
        • Contact:
        • Principal Investigator:
          • Alik Faber, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Active, not recruiting
        • Dermatology, PLLC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Advanced Foot and Ankle Center
        • Contact:
        • Principal Investigator:
          • Cyaandi Dove, MD
    • New York
      • Bronx, New York, United States, 10467-2490
        • Not yet recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Evan Lipsitz, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Wound Care Clinic
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43205
      • Columbus, Ohio, United States, 43221
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • St Vincent Health Center
        • Principal Investigator:
          • Thomas Serena, MD
        • Contact:
      • Kittanning, Pennsylvania, United States, 16201
        • Recruiting
        • Armstrong County Memorial Hospital
        • Principal Investigator:
          • Thomas Serena, MD
        • Contact:
      • Warren, Pennsylvania, United States, 16365
        • Recruiting
        • Penn North Centers for Advanced Wound Care
        • Contact:
        • Principal Investigator:
          • Thomas Serena
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Recruiting
        • Roger Williams Medical Centre
        • Contact:
        • Principal Investigator:
          • Vincent Falanga, MD
    • Washington
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center
        • Contact:
      • Yakima, Washington, United States, 98902
        • Active, not recruiting
        • Central Washington Podiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Individuals who have a graft-ready venous leg ulcer of at least 3 months duration, which has not, responded to standard conventional therapy.
  2. Individuals who have an Ankle Brachial Pressure Index (ABPI/ABI) of greater than or equal to 0.8 measured by Doppler sonography.
  3. 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.
  4. Individuals who have a target wound which is between 2 cm2 to 20 cm2 in area at the screening assessment.
  5. Individuals who are ambulatory.
  6. Individuals who have voluntarily signed and dated a patient IRB/EC approved Informed Consent Form (ICF).
  7. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Individuals younger than 18 years of age.
  5. 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.
  6. Individuals who have exposed bone, tendon or fascia visible around the target wound.
  7. Individuals with evidence of collagen vascular diseases, such as vasculitis or rheumatoid arthritis, under active treatment.
  8. Individuals with evidence of cellulitis or osteomyelitis during the previous 4 weeks.
  9. 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.
  10. 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.
  11. Individuals who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.
  12. Individuals who have chronic renal insufficiency requiring haemodialysis.
  13. Individuals who have received short course corticosteroids within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
  14. 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.
  15. Individuals who have participated in a clinical study of any investigational product within 2 months prior to treatment.
  16. Individuals who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  17. Individuals previously enrolled/randomized in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Overall rate of wound area reduction during treatment.
Time to first closure.
Incidence of closure at 16, 20 and 24 weeks.
Incidence of reopening at up to 16, 20 and 24 weeks.
Incidence of re-closure at 16, 20 and 24 weeks.
Qualitative levels of wound pain.
Percentage of Day 0 wound surface area.
Percentage reduction in wound surface area from previous visit.
Percentage reduction in wound surface area from Day 0.
Appearance of new ulcer in the target wound area post closure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intercytex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

February 5, 2008

Last Update Submitted That Met QC Criteria

February 4, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-VLU-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leg Ulcer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe