Wound healing, venous leg ulcers Circulatory System Phlebitis and thrombophlebitis of superficial vessels of lower extremities
Conditions
Interventions
All participants will receive standard care (debridement as necessary, dressing change, compressing therpy) once a week for 4 weeks
this is in order to standardise care prior to randomisation.
Intervention:
Application of MIST ultrasound therapy (between 4 and 12 minutes duration, depending on wound area) 3 times a week
combined with standard care 3 times a week (this will comprise debridement as necessary, dressing change and compression therapy change) for 8 weeks.
Comparator:
Standard care once a week (dressing
Sponsors
Cardiff and Vale University Health Board (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Venous leg ulcers (as diagnosed by the clinician) 2. Ankle Brachial Pressure Index (ABPI) >0.8 3. If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer 4. Age: 18 years or older 5. Ulcer size: Between 5 cm2 and 100 cm2 (with no longest length being greater than 10 cm) at randomisation point (week 5) 6. Mobility: Ability to attend clinic 7. Index ulcer between 6 weeks and 5 years duration prior to screening date
Exclusion criteria
Exclusion criteria: 1. Uncontrolled diabetes (Hba1c >=12%) as tested within the past 3 months 2. Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics 3. Renal failure 4. Index ulcer has exposed tendons, ligaments, muscle, or bone 5. Osteomyelitis or cellulitis or gangrene in study limb 6. Subjects with amputation above a trans metatarsal amputation (TMA) in the study limb 7. Subjects with active malignancy on the study limb 8. Index ulcer that is of arterial disease aetiology 9. Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study 10. Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 6 weeks post-operatively 11. Planned surgical procedure during the study period for the index wound 12. Prior skin replacement, negative pressure therapy, ultrasound therapy applied to the index wound 2 weeks before screening 13. Oral or IV antibiotics within 48 hours of baseline measurements 14. Growth factor therapy within previous 14 days of screening date 15. Currently receiving or has received radiation or chemotherapy within 3 months of randomisation 16. Pregnant or breast feeding women 17. Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial 18. Subject's wound would require ultrasound near an electronic implant or prosthesis 19. Subjects lacking capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage and actual (cm2) change in wound area between baseline and exit visits. Wound area will be measured using a digital imaging device which digitally photographs the wound and allows accurate tracing of the wound boundary. A single blinded assessor will perform all tracing and measurements to reduce the risk of bias and improve consistency. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in health related quality of life (HRQoL) between baseline and exit visits. This will be measured using a validated tool, the Cardiff Wound Impact Schedule (CWIS). This questionnaire consists of three areas: 1. Physical symptoms and daily living 2. Social life 3. Wellbeing. The patient also provides a global HRQoL score and satisfaction with HRQoL. The number wound infections (as demonstrated by clinical symptoms) suffered by each patient from beginning of treatment (week 5) to end of treatment (week 13). Wound characteristics including wound condition, exudate, pain frequency, pain severity, and odour. These will be assessed by experienced wound healing researchers. Proportion of wounds which remain healed 90 days after the end of the study. This outcome will be assessed by a single question phone call (conducted by a research nurse). | — |
Countries
United Kingdom
Outcome results
None listed