Status:
COMPLETED
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Lead Sponsor:
RegeneRx Biopharmaceuticals, Inc.
Collaborating Sponsors:
sigma-tau i.f.r. S.p.A.
Conditions:
Venous Stasis Ulcers
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
Detailed Description
The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with V...
Eligibility Criteria
Inclusion
- Informed Consent Form signed by the patient
- Male or female, between 18 and 79 years of age
- At least one venous leg ulceration stable for at least 6 weeks before enrollment
- Surface area between 3 and 30 cm2
Exclusion
- Have clinical evidence of active infection on the index ulcer
- Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
- Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
- History of adverse reaction to any ingredients of the study medication
- Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
- Current or former malignancy
- Arterial disorder resulting in ulcerated ulcers
- Diabetes mellitus
- Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00832091
Start Date
July 1 2006
End Date
January 1 2009
Last Update
March 30 2010
Active Locations (8)
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1
Chirurgia Vascolare
Bologna, Italy
2
Università degli Studi di Napoli - Federico II
Naples, Italy
3
Azienda Ospedaliera di Padova
Padua, Italy
4
Unità Operativa di Angiologia Azienda Ospedaliera di Padova
Padua, Italy