Study of Thymosin Beta 4 in Patients With Pressure Ulcers

This study has been completed.
Sponsor:
Information provided by:
RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00382174
First received: September 26, 2006
Last updated: January 6, 2010
Last verified: January 2010

September 26, 2006
January 6, 2010
May 2006
December 2008   (final data collection date for primary outcome measure)
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]
• To evaluate the safety and tolerability of Thymosin Beta 4 (Tβ4), administered topically once daily for up to 84 days, in patients with pressure ulcers
Complete list of historical versions of study NCT00382174 on ClinicalTrials.gov Archive Site
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]
• To evaluate the wound healing effectiveness of Tβ4, administered topically qd for up to 84 days, in patients with pressure ulcers
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pressure Ulcers
  • Drug: Placebo
    Topical administration of 0.00% thymosin beta 4 qd 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
  • Placebo Comparator: 1
    0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Thymosin Beta 4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2008
December 2008   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382174
SSPU
No
David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
RegeneRx Biopharmaceuticals, Inc.
Not Provided
Principal Investigator: Terry Treadwell, MD Institute for Advanced Wound Care
RegeneRx Biopharmaceuticals, Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP