Study of Thymosin Beta 4 in Patients With Pressure Ulcers

A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Drug: Placebo; Drug: Thymosin Beta 4

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36111
      • Institute for Advanced Wound Care
  • California
    • Beverly Hills, California, United States, 90211
      • Impact Clinical Trials
    • Long Beach, California, United States, 90822
      • Long Beach VAMC
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Medical Center
    • Miami, Florida, United States, 33115
      • A+ Research, Inc.
    • Mount Dora, Florida, United States, 32757
      • Mount Dora Research Center, Inc.
  • Illinois
    • Hines, Illinois, United States, 60141
      • Hines VAMC
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Wound Healing Laboratory Plastic Surgery UMass Medical Center
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Hospital
  • Pennsylvania
    • Warren, Pennsylvania, United States, 16365
      • New Bridge Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; 0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days	Drug: Placebo; Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Active Comparator: 2; 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	Drug: Thymosin Beta 4; Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Incidence of wound healing at the end of the study, Day 84	Up to 84 days

Collaborators and Investigators

• Sponsor: RegeneRx Biopharmaceuticals, Inc.
• Investigators: Principal Investigator: Terry Treadwell, MD, Institute for Advanced Wound Care

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 26, 2006
• First Submitted That Met QC Criteria: September 26, 2006
• First Posted (Estimate): September 28, 2006

Study Record Updates

• Last Update Posted (Estimate): February 1, 2010
• Last Update Submitted That Met QC Criteria: January 6, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Thymosin Beta 4; pressure ulcers; cutaneous wound- healing; chronic wound-healing; laminin-5
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: SSPU