Study of Thymosin Beta 4 in Patients With Pressure Ulcers

• ClinicalTrials.gov Identifier: NCT00382174
• Recruitment Status: Completed
• First Posted: September 28, 2006
• Results First Posted: February 1, 2010
• Last Update Posted: February 1, 2010
• Sponsor: RegeneRx Biopharmaceuticals, Inc.
• Information provided by: RegeneRx Biopharmaceuticals, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pressure Ulcers	Drug: Placebo; Drug: Thymosin Beta 4	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days [ Time Frame: Up to 84 days ]
   Incidence of wound healing at the end of the study, Day 84

Eligibility Criteria

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

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.)

Contacts and Locations

Locations

United States, Alabama

Institute for Advanced Wound Care

Montgomery, Alabama, United States, 36111

United States, California

Impact Clinical Trials

Beverly Hills, California, United States, 90211

Long Beach VAMC

Long Beach, California, United States, 90822

United States, Florida

Bay Pines VA Medical Center

Bay Pines, Florida, United States, 33744

A+ Research, Inc.

Miami, Florida, United States, 33115

Mount Dora Research Center, Inc.

Mount Dora, Florida, United States, 32757

United States, Illinois

Hines VAMC

Hines, Illinois, United States, 60141

United States, Massachusetts

Wound Healing Laboratory Plastic Surgery UMass Medical Center

Worcester, Massachusetts, United States, 01655

United States, New York

New York Presbyterian Hospital

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina Hospital

Chapel Hill, North Carolina, United States, 27599

United States, Pennsylvania

New Bridge Medical Center

Warren, Pennsylvania, United States, 16365

United States, Virginia

Mcguire VA Medical Center

Richmond, Virginia, United States, 23249

Sponsors and Collaborators

RegeneRx Biopharmaceuticals, Inc.

Investigators

• Principal Investigator: Terry Treadwell, MD; Institute for Advanced Wound Care

More Information

• Responsible Party: David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00382174
• Other Study ID Numbers: SSPU
• First Posted: September 28, 2006
• Results First Posted: February 1, 2010
• Last Update Posted: February 1, 2010
• Last Verified: January 2010

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:

pressure ulcers; cutaneous wound- healing; chronic wound-healing; Thymosin Beta 4; laminin-5

Additional relevant MeSH terms:

Pressure Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases