7th September 2012
NICE-recommended clinical trial due to start on promising Welsh wound healing device
The first clinical trial resulting from NICE medical technology guidance recommendations is due to start soon on a device to promote wound healing. NICE issued guidance in 2011 strongly encouraging further research on the use of the MIST Therapy system in chronic wounds, comparing it with standard care.
The Medical Technologies Advisory Committee’s view was that the device shows promise, but there was not yet enough evidence of sufficient quality to enable a recommendation for routine adoption of its use. The forthcoming clinical trial is the first significant output of the capacity that NICE has put in place for facilitating the development of further evidence, stemming from recommendations by NICE medical devices and diagnostics advisory bodies. The trial on the MIST Therapy system will recruit 40 patients with chronic venous leg ulcers, and will be undertaken independently by Cardiff University and Cardiff and Vale University Health Board.
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 device manufacturer 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 8 weeks of treatment, between patients treated with MIST plus standard care, and those receiving standard care alone.
NICE medical technology guidance aims to help new medical technologies, or innovative modifications to existing ones, to be used more quickly and consistently in the NHS across England. In particular, the Medical Technologies Advisory Committee (MTAC) looks at whether a device offers benefits to the patient and the NHS at a lower cost compared with similar products, or increased benefits for equal cost. In producing the 2011 guidance on the MIST Therapy system, the Committee recognised that there is a general lack of good quality evidence in the area of wound care. An important feature of the NICE Medical Technologies Evaluation Programme is facilitating the development of further independent evidence. Where MTAC identifies that a technology has considerable potential but insufficient evidence to support widespread adoption across the NHS, it may make recommendations for further research, as it did in the case of MIST. NICE is not involved in the trial or the research protocols; this is handled by external assessment centres which facilitate the development of further relevant evidence, and assist device manufacturers as part of this process.
In addition to the research recommendation, MTAC also advised that current users of the MIST Therapy system who are unable to join research studies should use NICE’s audit criteria to collect further information on healing rates, duration of treatment and quality of life and publish their results. NICE plans to review the 2011 guidance when new and substantive evidence becomes available.
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. While this further research is undertaken, it’s important to stress that more data can be generated and collected by all who use the device, to help inform further considerations on its clinical utility. As set out in the recommendations, NICE will review this guidance when new and substantive evidence becomes available. We hope that for manufacturers, this new research milestone will highlight further potential benefits of notifying their device to the NICE Medical Technologies Evaluation Programme.”
Professor Keith G Harding, Chief Investigator, Wound Healing Research Unit, 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; 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 review the original guidance, in deciding whether patients with chronic wounds would benefit from being treated using MIST.”