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

NCT00232973 | Unknown Phase 3 DMC

• 1 other identifier: 02-VLU-003
• Study Type: interventional
• Target: 396
• Locations: 3 countries
• Sites: 58

Brief 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.

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (10)

• 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.

Interventions

ICXP007 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Intercytex: lead

Study Sites (58)

Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

TERMINATED

HOPE Research Institute

Phoenix, Arizona, 85050, United States

RECRUITING

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

RECRUITING

Alameda County Medical Center

Alameda, California, 94602, United States

WITHDRAWN

Manzainto Medical Clinic

Carmichael, California, 95608, United States

RECRUITING

Bay Area Foot Care

Castro Valley, California, 94546, United States

ACTIVE NOT RECRUITING

M Limova, MD

Fresno, California, 93711, United States

ACTIVE NOT RECRUITING

VA Medical Center

Sacramento, California, 95655, United States

ACTIVE NOT RECRUITING

Bay Area Foot care

San Francisco, California, 94115, United States

ACTIVE NOT RECRUITING

University of Florida, Department of Surgery

Gainesville, Florida, 32610, United States

TERMINATED

Dr Francisco Kerdel

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

Doctor's Research Network

Miami, Florida, 33143, United States

RECRUITING

Dermatology and Cosmetic Specialists

Miramar, Florida, 33027, United States

TERMINATED

Dr. Robert Snyder

Tamarac, Florida, 33321, United States

RECRUITING

National Centre for Limb Preservation

Niles, Illinois, 60714, United States

RECRUITING

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

North Chicago, Illinois, 60064, United States

RECRUITING

Prairie Vascular Institute

Springfield, Illinois, 62702, United States

RECRUITING

The Wound Healing Center

Terre Haute, Indiana, 47807, United States

TERMINATED

Boston Medical Center, Department of Vascular Surgery

Boston, Massachusetts, 02118, United States

RECRUITING

Dermatology, PLLC

Ann Arbor, Michigan, 48103, United States

ACTIVE NOT RECRUITING

Advanced Foot and Ankle Center

Las Vegas, Nevada, 89119, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

NOT YET RECRUITING

UNC Wound Care Clinic

Chapel Hill, North Carolina, 27599, United States

RECRUITING

OSU Comprehensive Wound Center

Columbus, Ohio, 43205, United States

RECRUITING

OSU Comprehensive Wound Center

Columbus, Ohio, 43221, United States

RECRUITING

St Vincent Health Center

Erie, Pennsylvania, 16544, United States

RECRUITING

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

RECRUITING

Penn North Centers for Advanced Wound Care

Warren, Pennsylvania, 16365, United States

RECRUITING

Roger Williams Medical Centre

Providence, Rhode Island, 02908, United States

RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

Central Washington Podiatry

Yakima, Washington, 98902, United States

ACTIVE NOT RECRUITING

Western Canada Dermatology Institute

Edmonton, Alberta, T5J 3S9, Canada

TERMINATED

Clinical Trials Unit, Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

COMPLETED

Eastern Canada Cutaneous Research Associates Ltd

Halifax, Nova Scotia, B3H 1Z4, Canada

TERMINATED

Parkwood Hospital, St Joseph's Health Care

London, Ontario, N6C 2J1, Canada

RECRUITING

Gary Sibbald, MD

Mississauga, Ontario, L4Y 1A6, Canada

COMPLETED

Entralogix

Oakville, Ontario, L6K 1E1, Canada

RECRUITING

Dermatology Daycare

Toronto, Ontario, M5S 1B2, Canada

COMPLETED

St Michael's Hospital

Toronto, Ontario, M5W 1WB, Canada

RECRUITING

Entralogix

Welland, Ontario, L0S 1C0, Canada

RECRUITING

Centre Medical Ste-Dorothee

Laval, Quebec, H7X 3S5, Canada

COMPLETED

Department of Vascular Surgery, Manchester Royal Infirmary

Manchester, Lancashire, M13 9WL, United Kingdom

ACTIVE NOT RECRUITING

Clatterbridge Hospital, Surgical Outpatients

Upton, Wirral, CH49 5PE, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Belfast City Hospital

Belfast, BT9 1NR, United Kingdom

NOT YET RECRUITING

Birmingham Heartlands Hospital, University Department of Vascular Surgery

Birmingham, B9 5SS, United Kingdom

RECRUITING

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

ACTIVE NOT RECRUITING

Cardiff University

Cardiff, CF14 4XN, United Kingdom

RECRUITING

St Richards Hospital

Chichester, PO19 6SE, United Kingdom

NOT YET RECRUITING

Russells Hall Hospital

Dudley, DY1 2HQ, United Kingdom

RECRUITING

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

RECRUITING

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

RECRUITING

Vascular Surgical Unit, Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

TERMINATED

St George's Hospital

London, SW17 0QT, United Kingdom

NOT YET RECRUITING

Derriford Hospital

Plymouth, PL6 8HD, United Kingdom

RECRUITING

The Willows Centre for Health

Salford, M5 5JR, United Kingdom

NOT YET RECRUITING

Arrowe Park Hospital

Upton, CH49 5PE, United Kingdom

RECRUITING

Wrexham Maelor Hospital

Wrexham, LL13 7TD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: July 1, 2005
• Last Updated: February 5, 2008

Record last verified: 2008-02

Locations

CA (10); GB (17); US (31)