Clinical trial NCT00232973: Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Leg Ulcer
Lead sponsor: Intercytex
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall rate of wound area reduction during treatment.
measure: Time to first closure.
measure: Incidence of closure at 16, 20 and 24 weeks.
measure: Incidence of reopening at up to 16, 20 and 24 weeks.
measure: Incidence of re-closure at 16, 20 and 24 weeks.
measure: Qualitative levels of wound pain.
measure: Percentage of Day 0 wound surface area.
measure: Percentage reduction in wound surface area from previous visit.
measure: Percentage reduction in wound surface area from Day 0.
measure: Appearance of new ulcer in the target wound area post closure.
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Alameda
country: United States
facility: Alameda County Medical Center
state: California
city: Carmichael
country: United States
facility: Manzainto Medical Clinic
state: California
city: Castro Valley
country: United States
facility: Bay Area Foot Care
state: California
city: Fresno
country: United States
facility: M Limova, MD
state: California
city: Sacramento
country: United States
facility: VA Medical Center
state: California
city: San Francisco
country: United States
facility: Bay Area Foot care
state: California
city: Gainesville
country: United States
facility: University of Florida, Department of Surgery
state: Florida
city: Miami
country: United States
facility: Dr Francisco Kerdel
state: Florida
city: Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Miramar
country: United States
facility: Dermatology and Cosmetic Specialists
state: Florida
city: Tamarac
country: United States
facility: Dr. Robert Snyder
state: Florida
city: Niles
country: United States
facility: National Centre for Limb Preservation
state: Illinois
city: North Chicago
country: United States
facility: Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science
state: Illinois
city: Springfield
country: United States
facility: Prairie Vascular Institute
state: Illinois
city: Terre Haute
country: United States
facility: The Wound Healing Center
state: Indiana
city: Boston
country: United States
facility: Boston Medical Center, Department of Vascular Surgery
state: Massachusetts
city: Ann Arbor
country: United States
facility: Dermatology, PLLC
state: Michigan
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Wound Care Clinic
state: North Carolina
city: Columbus
country: United States
facility: OSU Comprehensive Wound Center
state: Ohio
city: Columbus
country: United States
facility: OSU Comprehensive Wound Center
state: Ohio
city: Erie
country: United States
facility: St Vincent Health Center
state: Pennsylvania
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: Warren
country: United States
facility: Penn North Centers for Advanced Wound Care
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Centre
state: Rhode Island
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Yakima
country: United States
facility: Central Washington Podiatry
state: Washington
city: Edmonton
country: Canada
facility: Western Canada Dermatology Institute
state: Alberta
city: Vancouver
country: Canada
facility: Clinical Trials Unit, Skin Care Centre
state: British Columbia
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd
state: Nova Scotia
city: London
country: Canada
facility: Parkwood Hospital, St Joseph's Health Care
state: Ontario
city: Mississauga
country: Canada
facility: Gary Sibbald, MD
state: Ontario
city: Oakville
country: Canada
facility: Entralogix
state: Ontario
city: Toronto
country: Canada
facility: Dermatology Daycare
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Welland
country: Canada
facility: Entralogix
state: Ontario
city: Laval
country: Canada
facility: Centre Medical Ste-Dorothee
state: Quebec
city: Manchester
country: United Kingdom
facility: Department of Vascular Surgery, Manchester Royal Infirmary
state: Lancashire
city: Upton
country: United Kingdom
facility: Clatterbridge Hospital, Surgical Outpatients
state: Wirral
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital, University Department of Vascular Surgery
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Chichester
country: United Kingdom
facility: St Richards Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Vascular Surgical Unit, Leeds General Infirmary
city: London
country: United Kingdom
facility: St George's Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Salford
country: United Kingdom
facility: The Willows Centre for Health
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
References: