NICE launches first clinical trial into medical device effectiveness

Independent research to decide on NHS use of innovative woundcare system

The MIST Therapy system delivers low-energy, low-intensity ultrasound to the base of the wound, promoting healing by stimulating tissue regeneration and removing dead tissue and bacteria

The new role of the National Institute for Health and Clinical Excellence (NICE) in testing the effectiveness of medical devices that could save the NHS money and improve patient outcomes was put into practise this week with the launch of the first clinical trial.

As part of its remit to draw up medical technology guidance recommendations for NHS trusts, NICE is launching a trial of the MIST Therapy chronic wound treatment system.

The probe follows comments last year by the Medical Technologies Advisory Committee, which claimed that while the technology showed promise, there was not enough evidence to enable a recommendation for routine adoption across the health service.

This trial, the first of its kind announced by NICE, will recruit 40 patients with chronic venous leg ulcers and will be undertaken independently by Cardiff University and Cardiff and Vale University Health Board.

There is a small amount of evidence to suggest that ulcers treated with MIST will heal more quickly than those having usual treatment and this trial will enable us to generate more independent evidence to show if this is actually the case

The MIST Therapy system claims to promote wound healing in chronic, hard-to-heal and acute wounds by delivering low-energy, low-intensity ultrasound to the base of the wound through a continuous saline mist. The mist acts as a channel for transmitting ultrasonic energy to the base of the wound, which aims to promote wound healing by stimulating tissue regeneration and removing dead tissue and bacteria. It is claimed by the manufacturer, Celleration, that it can improve healing rates, thus reducing treatment time and associated costs, and so offers advantages to both patients and the NHS. The trial objective is to determine if there is a difference in the mean change in wound area after eight weeks of treatment between patients treated with MIST plus standard care, and those receiving standard care alone.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “It’s excellent news that new clinical trials are due to start on the use of MIST Therapy system in line with the research recommended by the Medical Technologies Advisory Committee. The committee thought that the MIST system showed real promise, but there simply wasn’t the quantity and quality of evidence needed to support the case for adoption at that point.”

The results will help NICE when it comes to reviewing the original guidance in deciding whether patients with chronic wounds would benefit from being treated using MIST

She added that she hoped the trial would encourage other manufacturers to submit their own devices to the NICE Medical Technologies Evaluation Programme for future trials.

Professor Keith G Harding, chief investigator of wound healing research unit at Cardiff University, said: “We’re delighted to have received the go-ahead to start the trial on MIST, the medical device which may improve wound healing in hard-to-heal ulcers. There is a small amount of evidence to suggest that ulcers treated with MIST will heal more quickly than those having usual treatment and this trial will enable us to generate more independent evidence to show if this is actually the case. The results will then help NICE when it comes to reviewing the original guidance in deciding whether patients with chronic wounds would benefit from being treated using MIST.”

One patient who has already used the system is Michael, who was diagnosed with diabetes at the age of 32. Sixteen years later, he has undergone multiple surgical procedures, including two partial amputations of his feet due to complications caused by the condition.

MIST Therapy offers a new approach to woundcare

In 2009, he developed a wound on his right foot that led to an infection in the bones. This required his first surgical procedure where all of the toes of his right foot were removed. Unfortunately, due to a lack of blood flow and poorly controlled diabetes he had to undergo another surgery to remove the dead and infected tissue from his surgical wound. After this surgery, daily MIST Therapy treatments were added to his woundcare plan to help reduce the bacteria in the wound and to speed the rate of healing.

Within a few weeks of starting the treatment, his wound was filled with healthy granular tissue and after only six weeks the ulcer was completely healed. This eliminated the concern that additional amputations of his right foot would be needed.

He said: “When I had my wound, I was down and depressed, but MIST Therapy helped me feel better.”

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