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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Intercytex.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Intercytex
ClinicalTrials.gov Identifier:
NCT00232973
First received: October 4, 2005
Last updated: February 4, 2008
Last verified: February 2008
  Purpose
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.

Condition Intervention Phase
Leg Ulcer
Drug: ICXP007
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Intercytex:

Primary Outcome Measures:
  • Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 396
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232973

  Hide Study Locations
Locations
United States, Alabama
Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Manzainto Medical Clinic
Carmichael, California, United States, 95608
Bay Area Foot Care
Castro Valley, California, United States, 94546
M Limova, MD
Fresno, California, United States, 93711
VA Medical Center
Sacramento, California, United States, 95655
Bay Area Foot care
San Francisco, California, United States, 94115
United States, Florida
University of Florida, Department of Surgery
Gainesville, Florida, United States, 32610
Dr Francisco Kerdel
Miami, Florida, United States, 33136
Doctor's Research Network
Miami, Florida, United States, 33143
Dermatology and Cosmetic Specialists
Miramar, Florida, United States, 33027
Dr. Robert Snyder
Tamarac, Florida, United States, 33321
United States, Illinois
National Centre for Limb Preservation
Niles, Illinois, United States, 60714
Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science
North Chicago, Illinois, United States, 60064
Prairie Vascular Institute
Springfield, Illinois, United States, 62702
United States, Indiana
The Wound Healing Center
Terre Haute, Indiana, United States, 47807
United States, Massachusetts
Boston Medical Center, Department of Vascular Surgery
Boston, Massachusetts, United States, 02118
United States, Michigan
Dermatology, PLLC
Ann Arbor, Michigan, United States, 48103
United States, Nevada
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States, 89119
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
United States, North Carolina
UNC Wound Care Clinic
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
OSU Comprehensive Wound Center
Columbus, Ohio, United States, 43205
OSU Comprehensive Wound Center
Columbus, Ohio, United States, 43221
United States, Pennsylvania
St Vincent Health Center
Erie, Pennsylvania, United States, 16544
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
Penn North Centers for Advanced Wound Care
Warren, Pennsylvania, United States, 16365
United States, Rhode Island
Roger Williams Medical Centre
Providence, Rhode Island, United States, 02908
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Central Washington Podiatry
Yakima, Washington, United States, 98902
Canada, Alberta
Western Canada Dermatology Institute
Edmonton, Alberta, Canada, T5J 3S9
Canada, British Columbia
Clinical Trials Unit, Skin Care Centre
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Parkwood Hospital, St Joseph's Health Care
London, Ontario, Canada, N6C 2J1
Gary Sibbald, MD
Mississauga, Ontario, Canada, L4Y 1A6
Entralogix
Oakville, Ontario, Canada, L6K 1E1
Dermatology Daycare
Toronto, Ontario, Canada, M5S 1B2
St Michael's Hospital
Toronto, Ontario, Canada, M5W 1WB
Entralogix
Welland, Ontario, Canada, L0S 1C0
Canada, Quebec
Centre Medical Ste-Dorothee
Laval, Quebec, Canada, H7X 3S5
United Kingdom
Department of Vascular Surgery, Manchester Royal Infirmary
Manchester, Lancashire, United Kingdom, M13 9WL
Clatterbridge Hospital, Surgical Outpatients
Upton, Wirral, United Kingdom, CH49 5PE
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Belfast City Hospital
Belfast, United Kingdom, BT9 1NR
Birmingham Heartlands Hospital, University Department of Vascular Surgery
Birmingham, United Kingdom, B9 5SS
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Cardiff University
Cardiff, United Kingdom, CF14 4XN
St Richards Hospital
Chichester, United Kingdom, PO19 6SE
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Vascular Surgical Unit, Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
St George's Hospital
London, United Kingdom, SW17 0QT
Derriford Hospital
Plymouth, United Kingdom, PL6 8HD
The Willows Centre for Health
Salford, United Kingdom, M5 5JR
Arrowe Park Hospital
Upton, United Kingdom, CH49 5PE
Wrexham Maelor Hospital
Wrexham, United Kingdom, LL13 7TD
Sponsors and Collaborators
Intercytex
  More Information

Responsible Party: Intercytex
ClinicalTrials.gov Identifier: NCT00232973     History of Changes
Other Study ID Numbers: 02-VLU-003 
Study First Received: October 4, 2005
Last Updated: February 4, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on December 02, 2016