MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers.

Completed

• Conditions: Wound healing, venous leg ulcers; Circulatory System; Phlebitis and thrombophlebitis of superficial vessels of lower extremities

• Registration Number: ISRCTN24438635
• Lead Sponsor: Cardiff and Vale University Health Board (UK)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/25619411

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-16
• Study Completion: 2013-10-31
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified