Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Phase 2

Completed

• Conditions: Pressure Ulcers
• Interventions: Drug: Placebo; Drug: Thymosin Beta 4

• Registration Number: NCT00382174
• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

Brief 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

Detailed Description

The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-29
• Status Verified: 2010-01
• Results First Submitted QC: 2010-01-06
• Last Update Submitted: 2010-01-06
• Results First Posted: 2010-02-01
• Last Update Posted: 2010-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
2	Thymosin Beta 4	3 doses of thymosin beta 4: 0.01% w/w, 0.02% w/w, and 0.1% w/w, administered topically once daily for up to 84 days

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days	Up to 84 days	All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population

Secondary Outcome Measures

Name	Time	Method
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Up to 84 days	Incidence of wound healing at the end of the study, Day 84

Trial Locations

Locations (12)

Impact Clinical Trials; 🇺🇸 Beverly Hills, California, United States

Hines VAMC; 🇺🇸 Hines, Illinois, United States

Institute for Advanced Wound Care; 🇺🇸 Montgomery, Alabama, United States

Wound Healing Laboratory Plastic Surgery UMass Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Long Beach VAMC; 🇺🇸 Long Beach, California, United States

Bay Pines VA Medical Center; 🇺🇸 Bay Pines, Florida, United States

Mount Dora Research Center, Inc.; 🇺🇸 Mount Dora, Florida, United States

New Bridge Medical Center; 🇺🇸 Warren, Pennsylvania, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

A+ Research, Inc.; 🇺🇸 Miami, Florida, United States

University of North Carolina Hospital; 🇺🇸 Chapel Hill, North Carolina, United States

Mcguire VA Medical Center; 🇺🇸 Richmond, Virginia, United States