Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382174
• Other study ID #: SSPU
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: January 6, 2010
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: RegeneRx Biopharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Drug:
• Placebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
• Thymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

Locations

Country	Name	City	State
United States	Bay Pines VA Medical Center	Bay Pines	Florida
United States	Impact Clinical Trials	Beverly Hills	California
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Hines VAMC	Hines	Illinois
United States	Long Beach VAMC	Long Beach	California
United States	A+ Research, Inc.	Miami	Florida
United States	Institute for Advanced Wound Care	Montgomery	Alabama
United States	Mount Dora Research Center, Inc.	Mount Dora	Florida
United States	New York Presbyterian Hospital	New York	New York
United States	Mcguire VA Medical Center	Richmond	Virginia
United States	New Bridge Medical Center	Warren	Pennsylvania
United States	Wound Healing Laboratory Plastic Surgery UMass Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
RegeneRx Biopharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of Thymosin Beta 4 (Tß4)Applied for up to 84 Days		Up to 84 days	Yes
Secondary	Wound Healing Effectiveness of Tß4 Applied for up to 84 Days		Up to 84 days	No