Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.
• Collaborator: sigma-tau i.f.r. S.p.A.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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