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

Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00232973
• Other study ID #: 02-VLU-003
• Status: Recruiting
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: February 4, 2008
• Start date: July 2005

Study information

• Verified date: February 2008
• Source: Intercytex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer

Intervention

Drug:
• ICXP007

Locations

Country	Name	City	State
Canada	Western Canada Dermatology Institute	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates Ltd	Halifax	Nova Scotia
Canada	Centre Medical Ste-Dorothee	Laval	Quebec
Canada	Parkwood Hospital, St Joseph's Health Care	London	Ontario
Canada	Gary Sibbald, MD	Mississauga	Ontario
Canada	Entralogix	Oakville	Ontario
Canada	Dermatology Daycare	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Clinical Trials Unit, Skin Care Centre	Vancouver	British Columbia
Canada	Entralogix	Welland	Ontario
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Birmingham Heartlands Hospital, University Department of Vascular Surgery	Birmingham
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Cardiff University	Cardiff
United Kingdom	St Richards Hospital	Chichester
United Kingdom	Russells Hall Hospital	Dudley
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Vascular Surgical Unit, Leeds General Infirmary	Leeds
United Kingdom	St George's Hospital	London
United Kingdom	Department of Vascular Surgery, Manchester Royal Infirmary	Manchester	Lancashire
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	The Willows Centre for Health	Salford
United Kingdom	Arrowe Park Hospital	Upton
United Kingdom	Clatterbridge Hospital, Surgical Outpatients	Upton	Wirral
United Kingdom	Wrexham Maelor Hospital	Wrexham
United States	Alameda County Medical Center	Alameda	California
United States	Dermatology, PLLC	Ann Arbor	Michigan
United States	Boston Medical Center, Department of Vascular Surgery	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Manzainto Medical Clinic	Carmichael	California
United States	Bay Area Foot Care	Castro Valley	California
United States	UNC Wound Care Clinic	Chapel Hill	North Carolina
United States	OSU Comprehensive Wound Center	Columbus	Ohio
United States	OSU Comprehensive Wound Center	Columbus	Ohio
United States	St Vincent Health Center	Erie	Pennsylvania
United States	M Limova, MD	Fresno	California
United States	University of Florida, Department of Surgery	Gainesville	Florida
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	Advanced Foot and Ankle Center	Las Vegas	Nevada
United States	Doctor's Research Network	Miami	Florida
United States	Dr Francisco Kerdel	Miami	Florida
United States	Dermatology and Cosmetic Specialists	Miramar	Florida
United States	Institute for Advanced Wound Care	Montgomery	Alabama
United States	National Centre for Limb Preservation	Niles	Illinois
United States	Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science	North Chicago	Illinois
United States	HOPE Research Institute	Phoenix	Arizona
United States	Roger Williams Medical Centre	Providence	Rhode Island
United States	VA Medical Center	Sacramento	California
United States	Bay Area Foot care	San Francisco	California
United States	Prairie Vascular Institute	Springfield	Illinois
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Dr. Robert Snyder	Tamarac	Florida
United States	The Wound Healing Center	Terre Haute	Indiana
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Penn North Centers for Advanced Wound Care	Warren	Pennsylvania
United States	Central Washington Podiatry	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Intercytex

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.		12 weeks
Secondary	Overall rate of wound area reduction during treatment.
Secondary	Time to first closure.
Secondary	Incidence of closure at 16, 20 and 24 weeks.
Secondary	Incidence of reopening at up to 16, 20 and 24 weeks.
Secondary	Incidence of re-closure at 16, 20 and 24 weeks.
Secondary	Qualitative levels of wound pain.
Secondary	Percentage of Day 0 wound surface area.
Secondary	Percentage reduction in wound surface area from previous visit.
Secondary	Percentage reduction in wound surface area from Day 0.
Secondary	Appearance of new ulcer in the target wound area post closure.