Study of Thymosin Beta 4 in Patients With Pressure Ulcers

RegeneRx Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pressure Ulcers

Treatments: Drug: Placebo; Drug: Thymosin Beta 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382174

SSPU

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

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

Treatment:

Drug: Thymosin Beta 4