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.”

ENDS

Notes to Editors

About the guidance

1. The trial will be undertaken by the Wound Healing Research Unit (WHRU; Cardiff University) and Cedar (Cardiff and Vale University Health Board). The full title of the trial is: ‘Pragmatic randomised controlled trial of MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers'. The RCT will recruit 40 people with chronic venous leg ulcers; 20 will be treated with MIST three times a week combined with standard care and 20 with standard care once a week. The trial aims to have at least 34 completed patients. The trial is funded by Celleration, the manufacturer of the MIST Therapy system, through an unrestricted research grant.

2. The MIST Therapy system guidance was published in July 2011. NICE's audit tool in support of further data collection is also available at this link.

3. The full recommendation from the 2011 NICE guidance:

“1.1 The MIST Therapy system shows potential to enhance the healing of chronic,

'hard-to-heal', complex wounds, compared with standard methods of wound management. If this potential is substantiated then MIST could offer advantages to both patients and the NHS.

1.2 The amount and quality of published evidence on the relative effectiveness of the MIST Therapy system is not sufficient, at the time of writing, to support the case for routine adoption of the MIST Therapy system in the NHS.

1.3 Comparative research is recommended in the UK to reduce uncertainty about the outcomes of patients with chronic, 'hard-to-heal', complex wounds treated by the MIST Therapy system compared with those treated by standard methods of wound care. This research should define the types and chronicity of wounds being treated and the details of other treatments being used. It should report healing rates, durations of treatment (including debridement) needed to achieve healing, and quality of life measures (including quality of life if wounds heal only partially). It is recommended that centres using the MIST

Therapy system take part in research that delivers these outcomes. 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.

1.4 NICE will review this guidance when new and substantive evidence becomes available.”

4. NICE has appointed external assessment centres to support guidance production and associated processes. Part of their remit links to what happens when medical technology guidance recommends further research. In such cases, the external assessment centre will play a key role in facilitating the development of further relevant independent evidence, and assisting manufacturers as part of this process.

5. The MIST Therapy system is manufactured by Celleration. The annual rental price of the MIST Therapy system stated in the manufacturer's submission is £7500. The non-contact MIST Therapy treatment lasts between five and seven minutes and is carried out three times a week, at the same time as wound dressings are changed. The system is intended for use as an adjunct to standard wound care with dressings and other cleaning or debridement as necessary.

About the Medical Technologies Evaluation Programme

6. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information

About NICE

7. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

8. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

9. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
• Commissioning Outcomes Framework - NICE develops the potential indicators for the COF, the scheme starting in 2013, which will help measure the health outcomes and quality of care commissioned by Clinical Commissioning Groups.

10. NICEprovides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.