N/A
N=47
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Varicose Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01671748 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Percentage Change in Wound Area — -39.2; -46.6 percentage change in wound area — p=0.565
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MIST ultrasound therapy (Device); Standard Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiff and Vale University Health Board
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Wound Area |
-39.2; -46.6 | 0.565 |
| PRIMARY Actual Change in Wound Area |
-5.3; -6.2 | 0.618 |
| SECONDARY Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit) |
0; -1 | 0.490 |
| SECONDARY Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit) |
-5.27; -14.35 | 0.078 |
| SECONDARY Incidence of Wound Infection |
2; 2 | 0.346 |
| SECONDARY Number of Non-serious Adverse Events in Each Group |
70; 59 | — |
| SECONDARY Wound Recurrence Rate |
1; 2 | — |
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.
Eligibility 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 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
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.
Data sourced from ClinicalTrials.gov (NCT01671748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.