MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celleration, Inc.
Information provided by (Responsible Party):
Professor Keith G Harding, Cardiff University
ClinicalTrials.gov Identifier:
NCT01671748
First received: August 21, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging 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 UK standard practice. This will be assessed by measuring any reduction in wound size in the two groups after receiving 8 weeks of either Standard Care once a week or MIST combined with Standard Care three times a week.


Condition Intervention
Varicose Ulcer
Device: MIST ultrasound therapy
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Randomised Controlled Trial of MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers.

Resource links provided by NLM:


Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:
  • Wound area [ Time Frame: Weeks 1 to 13 (weekly) ] [ Designated as safety issue: No ]
    Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.


Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: Week 1 (start) and week 13 (exit) ] [ Designated as safety issue: No ]
    Change in health related quality of life between start and end of the study is assessed using a validated questionnaire, the Cardiff Wound Impact Schedule (CWIS).


Other Outcome Measures:
  • Incidence of wound infection [ Time Frame: Weeks 1 to 13 (weekly) ] [ Designated as safety issue: No ]
    The number of wound infections (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13)

  • Wound characteristics [ Time Frame: Weeks 1 to 13 (weekly) ] [ Designated as safety issue: No ]
    Wound characteristics including wound condition, exudate, pain frequency, pain severity, and odour will be assessed weekly.

  • Wound recurrence rate [ Time Frame: 90 days after time of healing ] [ Designated as safety issue: No ]
    Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
Standard treatment for VLUs is administered once a week, i.e. compression bandaging and non-adherent dressing, with debridement if required.
Other: Standard Care
Compression bandaging, non-adherent dressing, and debridement if required.
Experimental: MIST and Standard Care
MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Device: MIST ultrasound therapy
Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.
Other Names:
  • MIST non-contact low-frequecy ultrasound device
  • MIST
Other: Standard Care
Compression bandaging, non-adherent dressing, and debridement if required.

Detailed Description:

Venous leg ulcers (VLUs) are wounds which are often chronic and difficult to heal. VLUs affect between 1 and 3.2 people per 1000; they cause pain, reduced mobility and impact negatively on patients' quality of life (QoL). Standard treatment for patients with VLUs is the application of strong, sustained compression with bandages or stockings. This pragmatically-designed study aims to determine whether the use of a device called MIST used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. It will also show whether the MIST regimen improves participants' QoL and reduces the incidence of infection.

The MIST ultrasound system is a non-contact device which delivers low-frequency ultrasound through a gentle saline mist directed at a patient's wound. Patients (over 18 years old) will be invited to take part in this study if they have had a VLU for 6 weeks or more, which measures between 5 and 100 cm2, and is not infected. Participants with diabetes must show good blood glucose control, and those with underlying chronic disorders which may affect wound healing will be excluded.

All study participants will receive four weeks of standard treatment once a week at a single clinic at the Wound Healing Research Unit (WHRU), University Hospital of Wales. Patients whose wounds reduce by more than 40% during this time will be withdrawn from the study. Remaining patients will be randomly allocated to either the active group or the control group to receive a further eight weeks of treatment. Participants in the active group will receive treatment with the MIST device three times a week, as well as standard care (change of compression bandage and dressings) three times a week. The control group will receive UK standard care (which is dressing and compression bandage change at least once a week). The participants' ulcers will be measured and photographed once a week, and the wound characteristics will be assessed. Changes in participants' health related QoL will be assessed using a questionnaire at the beginning and end of the trial. Wound recurrence rates 90 days after the end of the treatment will be assessed by telephoning patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Venous leg ulcers (as diagnosed by the clinician)
  • Ankle Brachial Pressure Index (ABPI) >0.8
  • If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer
  • 18 years or older
  • Ulcer size of 5 cm2 - 100 cm2 (with no longest length being greater than 10 cm) at randomisation point (week 5)
  • Mobile enough to attend clinic
  • Index ulcer between 6 weeks and 5 years duration prior to screening date

Exclusion Criteria:

  • Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months
  • Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics
  • Renal failure
  • Index ulcer has exposed tendons, ligaments, muscle, or bone
  • Osteomyelitis or cellulitis or gangrene in study limb
  • Subjects with amputation above a trans metatarsal amputation (TMA) in the study limb
  • Subjects with active malignancy on the study limb
  • Index ulcer that is of arterial disease aetiology
  • Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
  • Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 6 weeks post-operatively
  • Planned surgical procedure during the study period for the index wound
  • Prior skin replacement, negative pressure therapy, ultrasound therapy applied to the index wound 2 weeks before screening
  • Oral or IV antibiotics within 48 hours of baseline measurements
  • Growth factor therapy within previous 14 days of screening date
  • Currently receiving or has received radiation or chemotherapy within 3 months of randomisation
  • Pregnant or breast feeding women
  • Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
  • Subject's wound would require ultrasound near an electronic implant or prosthesis
  • Subjects lacking capacity to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671748

Locations
United Kingdom
Wound Healing Research Unit, Cardiff University
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff and Vale University Health Board
Celleration, Inc.
Investigators
Principal Investigator: Keith G Harding, Professor Wound Healing Research Unit, Cardiff University
  More Information

No publications provided

Responsible Party: Professor Keith G Harding, Director - Institute for Translation, Innovation, Methodology and Engagement (TIME), Cardiff University
ClinicalTrials.gov Identifier: NCT01671748     History of Changes
Other Study ID Numbers: 12-SUR-5323
Study First Received: August 21, 2012
Last Updated: September 27, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Cardiff and Vale University Health Board:
Venous Leg Ulcer
Varicose Ulcer
Chronic ulcer
Chronic wound
Ultrasound therapy
MIST device
Wound healing
Low frequency non contact ultrasound

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014