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

Sponsor
Intercytex (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00232973
Collaborator
(none)
396
Enrollment
58
Locations
6.8
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
396 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Overall rate of wound area reduction during treatment. []

  2. Time to first closure. []

  3. Incidence of closure at 16, 20 and 24 weeks. []

  4. Incidence of reopening at up to 16, 20 and 24 weeks. []

  5. Incidence of re-closure at 16, 20 and 24 weeks. []

  6. Qualitative levels of wound pain. []

  7. Percentage of Day 0 wound surface area. []

  8. Percentage reduction in wound surface area from previous visit. []

  9. Percentage reduction in wound surface area from Day 0. []

  10. Appearance of new ulcer in the target wound area post closure. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Institute for Advanced Wound Care Montgomery Alabama United States 36111
2 HOPE Research Institute Phoenix Arizona United States 85050
3 Southern Arizona VA Health Care System Tucson Arizona United States 85723
4 Alameda County Medical Center Alameda California United States 94602
5 Manzainto Medical Clinic Carmichael California United States 95608
6 Bay Area Foot Care Castro Valley California United States 94546
7 M Limova, MD Fresno California United States 93711
8 VA Medical Center Sacramento California United States 95655
9 Bay Area Foot care San Francisco California United States 94115
10 University of Florida, Department of Surgery Gainesville Florida United States 32610
11 Dr Francisco Kerdel Miami Florida United States 33136
12 Doctor's Research Network Miami Florida United States 33143
13 Dermatology and Cosmetic Specialists Miramar Florida United States 33027
14 Dr. Robert Snyder Tamarac Florida United States 33321
15 National Centre for Limb Preservation Niles Illinois United States 60714
16 Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science North Chicago Illinois United States 60064
17 Prairie Vascular Institute Springfield Illinois United States 62702
18 The Wound Healing Center Terre Haute Indiana United States 47807
19 Boston Medical Center, Department of Vascular Surgery Boston Massachusetts United States 02118
20 Dermatology, PLLC Ann Arbor Michigan United States 48103
21 Advanced Foot and Ankle Center Las Vegas Nevada United States 89119
22 Montefiore Medical Center Bronx New York United States 10467-2490
23 UNC Wound Care Clinic Chapel Hill North Carolina United States 27599
24 OSU Comprehensive Wound Center Columbus Ohio United States 43205
25 OSU Comprehensive Wound Center Columbus Ohio United States 43221
26 St Vincent Health Center Erie Pennsylvania United States 16544
27 Armstrong County Memorial Hospital Kittanning Pennsylvania United States 16201
28 Penn North Centers for Advanced Wound Care Warren Pennsylvania United States 16365
29 Roger Williams Medical Centre Providence Rhode Island United States 02908
30 Madigan Army Medical Center Tacoma Washington United States 98431
31 Central Washington Podiatry Yakima Washington United States 98902
32 Western Canada Dermatology Institute Edmonton Alberta Canada T5J 3S9
33 Clinical Trials Unit, Skin Care Centre Vancouver British Columbia Canada V5Z 4E8
34 Eastern Canada Cutaneous Research Associates Ltd Halifax Nova Scotia Canada B3H 1Z4
35 Parkwood Hospital, St Joseph's Health Care London Ontario Canada N6C 2J1
36 Gary Sibbald, MD Mississauga Ontario Canada L4Y 1A6
37 Entralogix Oakville Ontario Canada L6K 1E1
38 Dermatology Daycare Toronto Ontario Canada M5S 1B2
39 St Michael's Hospital Toronto Ontario Canada M5W 1WB
40 Entralogix Welland Ontario Canada L0S 1C0
41 Centre Medical Ste-Dorothee Laval Quebec Canada H7X 3S5
42 Department of Vascular Surgery, Manchester Royal Infirmary Manchester Lancashire United Kingdom M13 9WL
43 Clatterbridge Hospital, Surgical Outpatients Upton Wirral United Kingdom CH49 5PE
44 Aberdeen Royal Infirmary Aberdeen United Kingdom AB25 2ZN
45 Belfast City Hospital Belfast United Kingdom BT9 1NR
46 Birmingham Heartlands Hospital, University Department of Vascular Surgery Birmingham United Kingdom B9 5SS
47 Bradford Royal Infirmary Bradford United Kingdom BD9 6RJ
48 Cardiff University Cardiff United Kingdom CF14 4XN
49 St Richards Hospital Chichester United Kingdom PO19 6SE
50 Russells Hall Hospital Dudley United Kingdom DY1 2HQ
51 Gloucestershire Royal Hospital Gloucester United Kingdom GL1 3NN
52 Hull Royal Infirmary Hull United Kingdom HU3 2JZ
53 Vascular Surgical Unit, Leeds General Infirmary Leeds United Kingdom LS1 3EX
54 St George's Hospital London United Kingdom SW17 0QT
55 Derriford Hospital Plymouth United Kingdom PL6 8HD
56 The Willows Centre for Health Salford United Kingdom M5 5JR
57 Arrowe Park Hospital Upton United Kingdom CH49 5PE
58 Wrexham Maelor Hospital Wrexham United Kingdom LL13 7TD

Sponsors and Collaborators

  • Intercytex

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00232973
Other Study ID Numbers:
  • 02-VLU-003
First Posted:
Oct 5, 2005
Last Update Posted:
Feb 5, 2008
Last Verified:
Feb 1, 2008
Additional relevant MeSH terms:
Leg Ulcer
Ulcer

Study Results

No Results Posted as of Feb 5, 2008