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MIST

Lay summary

Venous leg ulcers (VLUs) are wounds which are often chronic and difficult to heal. They cause pain, reduced mobility and impact negatively on patients' quality of life. Standard treatment for patients with VLUs is the application of strong, sustained compression with bandages or stockings. The MIST ultrasound system is a noncontact device which delivers low frequency ultrasound through a gentle saline mist directed at a patient's wound. This study aims to determine whether the use of the MIST device used in combination with standard treatments can improve healing of VLUs compared to current UK standard practice. It will also show whether the MIST regimen improves participants' quality of life and reduces the incidence of infection.

Cedar's role

Cedar managed this clinical trial on a medical device called MIST ultrasound therapy. Professor Keith Harding and his experienced team at the Wound Healing Research Unit (Cardiff University) conducted the research in partnership with Cedar who co-ordinated the trial, developed the protocol, and analysed the data.The trial looked at whether MIST improves wound healing in patients with chronic venous leg ulcers, and is the first trial resulting from National Institute for Health and Care Excellence (NICE) medical technology guidance recommendations.

Publication

The trial has now finished and the results have been published in a peer-reviewed journal article:  White, J., Ivins, N., Wilkes, A., Carolan-Rees, G., & Harding, K.G. (2016) Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trialInternational Wound Journal 13(5), 833-842.

Details of the MIST clinical trial:

  • Full title of clinical trial: Pragmatic randomised controlled trial of MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers.
  • Public title: MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers.
  • Chief Investigator: Professor K G Harding
  • Research Site: Wound Healing Research Unit, Cardiff University
  • Sponsor: Cardiff and Vale University Health Board
  • Funding: Unrestricted research grant from Celleration Inc.
  • Research Ethics Committee reference: 12/WA/0133
  • Current controlled trials: ISRCTN24438635
  • ClinicalTrials.gov number: NCT01671748