Preliminary Trial Results Suggest Sterilox Tx Solution is a Powerful New Treatment for Chronic Venous Leg Ulcers

RADNOR, Pa. -- Sterilox Technologies Inc., and the Department of Dermatology at Churchill Hospital in Oxford, UK, today announced positive, preliminary human clinical trial results of a new antiseptic wound  irrigation fluid for the treatment of chronic venous leg ulcers. Thirteen of  the 17 patients admitted to the study (76 percent), all of whom had previously failed at least two courses of standard treatment, benefited from a 12-week course of Sterilox Tx ulcer treatment. The ulcers of seven patients healed completely; for six others the size of their ulcerated areas was reduced by more than 50 percent. All patients reported a marked reduction or total elimination of pain when Sterilox Tx treatments were started, a result which continued throughout the remainder of the study.

   

"These early results suggest that treatment with Sterilox Tx wound

irrigant solution (CE marked) could provide clinicians with an effective way of treating wounds and alleviating the pain of chronic leg ulcers especially for patients who have failed an initial course of standard therapy," said David W. Anderson, president of Sterilox Technologies Inc.  "In addition, the Sterilox Tx solution may also accelerate healing for patients with less chronic disease, particularly where heavy bacterial colonization is present in

the wound."

   

Typically venous leg ulcers affect older people where the most common

symptoms are chronic inflammation of the ulcerated leg, debility, pain (often

so severe that patients need to take sleeping tablets at night), and social

stigma from infection.  According to the National Institutes of Health,

chronic wounds such as venous leg ulcers, pressure sores, ischemic ulcers and

diabetic foot ulcers, affect more than 4 million Americans each year and cost

about $9 billion to treat (NIH, http://www.clinicaltrials.gov/ct/gui/show/NCT00006437). 

   

The standard treatment for leg ulcers consists of compression bandaging

combined with anti-bacterial dressings over a period of 12 to 24 weeks. 

However around 30 percent of patients fail to respond to this treatment and become

long-term sufferers needing to undergo multiple and costly alternative

therapies in an attempt to alleviate their symptoms.

   

Sterilox Tx is a novel antiseptic solution comprising mainly hypochlorous

acid (>95 percent) as its active ingredient at pH 5.4 to 5.8.  The solution has

demonstrated extremely rapid bactericidal, virucidal and fungicidal action

against many organisms.  Sterilox Tx solutions have also shown lack of

toxicity in the wound care setting and are prepared at the point of use in the

clinically appropriate concentration for clinic or homecare therapy. 

   

Patients admitted to this clinical trial, which is ongoing, continued with their standard course of treatment but also received a 20-minute Sterilox Tx treatment.  Initially, this was conducted twice weekly for three weeks and then once per week for nine weeks.

   

Bacterial cell count studies showed that after one treatment with

Sterilox Tx, the microbial count in the patient's ulcer fluid was typically

reduced 10,000-fold.

   

In vitro cell culture studies have also shown that Sterilox Tx at the

concentration used within this trial (140 to 160ppm of free chlorine)

demonstrated no adverse affects on fibroblasts and keratinocytes.  Therefore,

the ability of Sterilox Tx solution to improve the outcome and markedly reduce

or eliminate pain for patients suffering chronic venous leg ulcers is due to

the solution's combined activities: as a potent microbiocide and its ability

to aid the healing process by not inhibiting normal cell growth.

   

These early trial results were presented to the wound care community at

the 2nd World Union of Wound Healing Societies Congress in Paris held in July.

Sterilox Technologies Inc. is now in active discussion with a number  of commercial partners to help introduce this novel approach more widely.

 

Source:  Sterilox Technologies Inc.

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