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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382174
Other study ID # SSPU
Secondary ID
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


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
See also
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Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT00763282 - Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) N/A
Completed NCT00771238 - Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds N/A
Completed NCT01885962 - Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers N/A