Treatment of Venous Stasis Ulcers. MedDRA version: 6.1 Level: HLT Classification code 10034638
Conditions
Interventions
Product Name: Thymosin Beta 4
Product Code: Tbeta4
Pharmaceutical Form: Gel
Current Sponsor code: Tbeta4
Concentration type: equal
Pharmaceutical form of the placebo: Gel
Route of administration of th
Sponsors
SIGMA-TAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled in this study only if they meet all of the following criteria 1.Male or female, between 18 and 79 years of age, with evidence of venous insufficiency as documented by venous duplex scanning or impedance plethysmography; 2.At least one venous leg ulceration index ulcer with a surface area between 3 and 30 cm2; and with a distance of at least 2.5 cm between the index ulcer and any other active ulcer; 3.Index ulcer stable for at least 6 weeks before enrollment; and 4.Informed Consent Form signed by the patient. 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: Patients will be enrolled in this study only if they meet none of the following criteria 1.Have the designated ulcer below the malleolus, on the foot, or above the base of the knee; 2.Have clinical evidence of active infection on the index ulcer; 3.Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment; 4.Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment; 5.History of adverse reaction to any ingredients of the study medication; 6.Clinically significant abnormalities on screening laboratory tests complete blood count including differential and platelets, coagulation, chemistry, and urinalysis ; 7.Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers; 8.Current or former malignancy; 9.Arterial disorder resulting in ulcerated ulcers; 10.Arterial insufficiency evidenced by an ankle brachial index ABI of 0.8. Subjects with an ABI 1.2 must have a toe brachial index of 0.6 or a supine transcutaneous oxygen measurement 30 mm Hg; 11.Diabetes mellitus; 12.Pregnant or lactating breastfeeding women. A serum pregnancy test will be performed at screening for female patients of childbearing potential; 13.Women who have had menarche but have not completed menopause 1 year or longer without a menstrual period , have not been surgically sterilized bilateral tubal ligation or hysterectomy , do not have a partner with documented sterility including vasectomy and are not using adequate contraception if sexually active; For this study adequate contraception means sexual abstinence or the use of combined oral contraceptives. 14.Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures, participate in all scheduled study assessments, or to complete the study; and 15.Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Thymosin Beta 4 Tbeta4 , administered topically once daily for up to 84 days in patients with venous stasis ulcers.;Secondary Objective: To evaluate the ulcer healing effectiveness of Tbeta4, administered topically once daily for up to 84 days in patients with venous stasis ulcers.;Primary end point(s): To evaluate the safety and tolerability of Thymosin Beta 4 Tbeta4 , administered topically once daily for up to 84 days in patients with venous stasis ulcers | — |
Countries
Italy
Outcome results
None listed