Phase 2
N=72
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Venous Stasis Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00832091 ↗Enrolled (actual)
72
Serious AEs
5.6%
Results posted
Mar 2010
Primary outcome: Primary: Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days — 24; 104 SAEs and AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymosin Beta 4 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days |
24; 104 | — |
| SECONDARY Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers |
4; 12 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00832091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.