Venous Insufficiency Leg Ulcers
Conditions
Interventions
Product Code: ICXP007
Pharmaceutical Form:
Other descriptive name: Human Dermal Fibroblasts
Concentration number: 3 x 10e6 cells-
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
Intercytex Limited
Eligibility
Sex/Gender
All
Inclusion 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 2 cc per second by APG. Duplex or PPG/APG will be used to establish venous insuffciency. Doppler will be utilized to rule out arterial disease. 4. Individuals who have a target wound which is between 2 cm squared to 20 cm squared in area at the screening assessment. 5. Individuals who are ambulatory. 6. Individuals who have voluntarily signed and dated a patient Informed Consent Form (ICF). 7. Individuals, who are, in the opinion of the investigator, able to understand this study, co-operate with teh study procedures and are willing to return to the clinci for all the required follow-up visits. 8. Sub-study only: Patients who are Female 9. Sub-study only: Have a coagulation profile which, in the opinion of the Investigator, would not result in excessive bleeding during biopsy procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Indiviudals with a known hypersensitivity to Aprotinin or any other constitutents of Tisseel VH S/D, 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 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 corticosteriods 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. 18. Sub-study only: Individuals who have a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 19. Individuals who have an abnormal PT, PTT or platelet value defined as 1.5 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant. 20. Sub-study only: Individuals who are taking more than 2 tablets of 81 mg Aspirin per day or any dose of Coumadin on a regular basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of ICXP007 in achieving 100% closure of non-infected skin ulcers of greater than 3 months duration due to venous insufficiency with four layer bandage compression therapy.;Secondary Objective: To compare four layer compression bandaging plus ICXP007 against both four layer compression bandaging plus placebo and the use of four layer compression bandaging alone in the treatment of non-infected skin ulcers due to chronic venous insufficiency.;Primary end point(s): Healing assessed by incidence of 100% closure (epithelialised) as determined by the investigator, at any time during the initial 12 weeks of the treatment period. This must be confirmed 2 weeks later in order to be classified as closure. | — |
Countries
United Kingdom
Outcome results
None listed