Phase 2
N=144
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00382174 ↗Enrolled (actual)
144
Serious AEs
—
Results posted
Feb 2010
Primary outcome: Primary: Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days — 18; 53; 71 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Thymosin Beta 4 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days |
18; 53; 71 | — |
| SECONDARY Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days |
3; 8; 11 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
Eligibility Criteria
Inclusion criteria
- Informed Consent Form signed by the patient or patient's legal representative
- Inpatients and outpatients
- At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure
- Surface area between 5 and 70 cm2
- Ulcer present and stable for at least 1 month before enrollment
Exclusion Criteria
- Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
- Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
- History of adverse events to any ingredients of study medication
- Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
- Arterial or venous disorder resulting in ulcerated wounds
- Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
- Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Data sourced from ClinicalTrials.gov (NCT00382174). 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.