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
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
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.