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

NCT01671748 | Completed Results

• 1 other identifier: 12-SUR-5323
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Ulcer

Keywords

Venous Leg Ulcer; Varicose Ulcer; Chronic ulcer; Chronic wound; Ultrasound therapy; MIST device; Wound healing; Low frequency non contact ultrasound

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Wound Area

  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.

  Week 5 to 13

• Actual Change in Wound Area

  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.

  Week 5 to 13

Secondary Outcomes (5)

• Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)

  Week 1 (start) and week 13 (exit)

• Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)

  Weeks 5 to 13

• Incidence of Wound Infection

  Weeks 5 to 13

• Number of Non-serious Adverse Events in Each Group

  Week 5 to 13

• Wound Recurrence Rate

  90 days after time of healing

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard treatment for VLUs is administered once a week, i.e. compression bandaging and non-adherent dressing, with debridement if required.

Other: Standard Care

MIST and Standard Care

EXPERIMENTAL

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; Other: Standard Care

Interventions

MIST ultrasound therapy DEVICE

Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.

Also known as: MIST non-contact low-frequecy ultrasound device, MIST

MIST and Standard Care

Standard Care OTHER

Compression bandaging, non-adherent dressing, and debridement if required.

MIST and Standard Care; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Ulcer size of 5 cm\^2 - 100 cm\^2 (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

You may not qualify if:

• Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months
• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Celleration, Inc.: collaborator

Study Sites (1)

Wound Healing Research Unit, Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Difference in treatment frequency between the groups which could potentially bias results. Standard deviation proved to be larger than estimated from the available literature which resulted in the study having reduced statistical power.

Results Point of Contact

• Title: Dr Judith White
• Organization: Cardiff and Vale University Health Board

judith.white3@wales.nhs.uk

02920744771

Study Officials

• Keith G Harding, Professor

  Wound Healing Research Unit, Cardiff University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Institute for Translation, Innovation, Methodology and Engagement (TIME)

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 26, 2015
• Results First Posted: August 26, 2015

Record last verified: 2015-07

Locations

GB (1)