Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Venous Stasis Ulcers
Interventions
DRUG

Thymosin Beta 4

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

DRUG

Placebo

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Trial Locations (8)

Unknown

Chirurgia Vascolare, Bologna

Università degli Studi di Napoli - Federico II, Naples

Azienda Ospedaliera di Padova, Padua

Unità Operativa di Angiologia Azienda Ospedaliera di Padova, Padua

Istituto Dermopatico dell'Immacolata (IDI), Rome

Klinika Chirurgii Naczyń i Angiologii, Lublin

Klinika Chirurgii Ogólnej i Naczyniowej,, Szczecin

Oddział Angiologiczny, Wroclaw

All Listed Sponsors
collaborator

sigma-tau i.f.r. S.p.A.

INDUSTRY

lead

RegeneRx Biopharmaceuticals, Inc.

INDUSTRY

NCT00832091 - Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers | Biotech Hunter | Biotech Hunter