Foot Ulcers Succumb to a New Healing System

DiabetesHealth.com, June/July 2007

Foot ulcers rank among the most dreaded complications of diabetes. The problem is caused by diabetic neuropathy, or deadening of the nerves in the lower limbs, which leads to unnoticed injuries. The resulting ulcers are exacerbated by reduced blood flow that chokes down the supply of oxygen to the injury.

Foot ulcers affect one out of six people with diabetes. After an ulcer has remained unhealed for more than a month, it is associated with a poor outcome, up to and including gangrene and amputation. People with diabetes undergo more than half of the amputations in the U.S., and the costs for treating diabetic foot ulcers and related amputations exceed $10 billion per year.

Ken Mitchell understands how stubborn foot ulcers can be. By 2005, he'd been trying to heal his ulcer for six years, but every conventional therapy had failed. He was at his wit's end, because the presence of the wound disqualified him for the kidney/pancreas transplant that he desperately needed.

Willing to try anything, he was nevertheless skeptical when he first sealed his ulcerated foot into an O₂Misly™ Wound Treatment System. After twelve treatments over the course of two months, however, his skepticism had evaporated, along with his foot ulcer. A few months later, he received the kidney/pancreas transplant he'd been waiting for.

O₂Misly™ is a new therapy for chronic wounds that have failed to respond to standard therapies. It delivers pure oxygen at atmospheric pressure, alternating with a hydrating mist suffused with antimicrobial agents, to bathe the wounded tissues. Wounds are first debrided (scraped down to clean tissue) in the standard manner, then placed in the device, where ten minutes of the anti-microbial mist alternates with five minutes of oxygen four times over the period of an hour. The mist opens microcapillaries and encourages blood flow, and the oxygen bath then encourages blood vessel growth. The one-hour treatment, which takes place two times weekly, costs $1000 a week. On average, says Adrian Pelkus, the company CEO, a wound will heal in six weeks.

Mr. Pelkus reports that in a clinical trial of patients who had failed current standards of care treatment, 75.5% of patients treated with O₂Misly™ healed within twelve weeks, compared with 24.2 percent of patients treated with standard care therapies. 100% of patients treated 20 weeks were healed with O₂Misly™, compared with 30.9 % of patients treated with standard care therapies.

O₂Misly™ takes pains to differentiate itself from topical hyperbaric oxygen therapy, or THBO, which enjoyed a temporary vogue about ten years ago. THBO was based upon applying slightly pressurized and humidified pure oxygen intermittently to a wound sealed inside an enclosure such as a sleeve, boot, or pouch. There were several FDA-approved systems for doing this, including some disposable inflatable chambers, but they suffered from a lack of clinical studies supporting their claims and a failure to obtain reimbursement from Medicare and large insurers.

O2Misly also differs from standard hyperbaric oxygen therapy, which requires a patient to enter a room that contains pure oxygen at pressures that can reach close to three times that of the normal atmosphere. Patients sit in the room for 90 to 120 minutes, breathing pressurized oxygen just as if they were undersea in a diving bell. Because the oxygen is pure and pressurized, their blood carries at least twice the oxygen to their wounds as it would normally, thereby accelerating healing.

Because hyperbaric oxygen therapy involves pressurizing the whole body in the same manner as deep sea diving, it has the potential to lead to pulmonary or nervous system toxicity, acceleration of cataract growth, and vision distortion. Its also expensive, costing approximately $6,000 a week. However, it is reimbursed by the insurance community as a valid treatment.

Currently there are two facilities at which O2Misly is available, both in Southern California. The company has been submitting its data on the healing powers of O2Misly to payers for reimbursement.

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