Study of Thymosin Beta 4 in Patients with Pressure Ulcers

In December of 2008, researchers initiated a study to test the effectiveness of Thymosin Beta 4 for treatment of bedsores. According to the study's description, it was a double-blind, placebo-controlled, dose-escalation study. Its purpose was to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4) when placed on the surface of the wound in patients with bedsores.

Bedsores primarily affect elderly, bedridden patients. Sustained pressure or constant friction of the body in areas that are susceptible to moisture and friction cause bed sores. Thymosin Beta 4 is a synthetic imitation of a natural amino acid peptide. This peptide has healing and anti-inflammatory qualities and can also cause the expression of laminin-5.

It was an interventional clinical trial with 72 participants. Researchers randomly administered a placebo to some subjects while giving Thymosin Beta 4 to others. Participants were between 18 and 85 years of age and of either sex. The inclusion criteria involved:

• Informed consent form signed by the patient or patient's legal representative
• Inpatients and outpatients
• At least one pressure ulcer with full-thickness skin loss and no joint capsule or bone exposure
• Surface area between 5 and 70 centimeters squared
• Ulcer present and stable for at least one month before enrollment

Terry Treadwell, MD, of the Institute for Advanced Wound Care, was the principle investigator. He conducted the study at multiple medical locations across the country under David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc. RegeneRx was the sponsor of the study, which concluded in December of 2008.

What is a Bedsore?

When continuous pressure afflicts an area of the body, the flow of blood can cut off. The resultant lack of oxygen starves the tissue and skin and they eventually wither away and die, leaving an open wound on the surface of the body. This open wound is a bedsore, pressure sore, pressure ulcer, or a decubitus ulcer.

Normal, healthy people move around enough that this does not become a problem. Any oxygen deprivation is short-lived and not detrimental. Even when we sleep, we roll over without realizing it. However, some people are immobile either because they are comatose or paralyzed or too weak to move. These people are at risk for developing bedsores.

How Do Doctors Treat Bedsores?

There are a number of treatments available for bedsores. A physician will choose the appropriate one or ones based on the severity of the bedsore along with other factors. The treatment options include:

• Debridement. Debridement is the removal of dead tissue to promote its replacement by healthy tissue. There are several kinds of debridement, including mechanical, biological, autolytic, surgical and chemical.
• Wound vacs. A wound vac, often used after a debridement, uses suction to drain a wound and a foam-like packing to keep it clean and uninfected.
• Flap reconstruction surgery. If a bedsore is advanced, it may require surgery to correct. With flap reconstruction, healthy skin from another part of the body goes over the wound.
• Colostomy. A colostomy bag is a preventative measure to keep fecal matter from entering and infecting the bedsore. Most comatose patients will require a colostomy bag and so will many paralyzed patients. Elderly patients also often require colostomy bags.
• Amputation. Amputation is the removal of a limb, in part or entirely. In severe cases of pressure sores, a limb may not be salvageable. In these cases, doctors will remove the necrotic tissue, saving as much of it as they can.

There are many forms and subforms of treatment for bedsores. The study on Thymosin Beta 4 was an attempt to add another option to treat bedsores, as researchers hoped the substance would promote healthy tissue growth in the pressure sores.