Trial Outcomes & Findings for MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers (NCT NCT01671748)
NCT ID: NCT01671748
Last Updated: 2015-08-26
Results Overview
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.
COMPLETED
NA
47 participants
Week 5 to 13
2015-08-26
Participant Flow
Study procedures took place in a single dedicated unit specialising in wound healing research, between August 2012 and November 2013.
All enrolled patients received 4 weeks of SOC prior to random allocation (run-in phase). Patients whose wounds reduced by \>40% in the first 4 weeks were withdrawn and did not progress to random allocation.
Participant milestones
| Measure |
Standard of Care
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
4 Week run-in Phase
STARTED
|
47
|
0
|
|
4 Week run-in Phase
COMPLETED
|
36
|
0
|
|
4 Week run-in Phase
NOT COMPLETED
|
11
|
0
|
|
12 Week Treatment Phase
STARTED
|
19
|
17
|
|
12 Week Treatment Phase
COMPLETED
|
19
|
17
|
|
12 Week Treatment Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Standard of Care
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
4 Week run-in Phase
Withdrawal by Subject
|
1
|
0
|
|
4 Week run-in Phase
Adverse Event
|
1
|
0
|
|
4 Week run-in Phase
Not eligible
|
9
|
0
|
Baseline Characteristics
MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
69 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
History of leg ulceration (months)
|
94.7 months
STANDARD_DEVIATION 83.2 • n=5 Participants
|
109.7 months
STANDARD_DEVIATION 112.2 • n=7 Participants
|
101.8 months
STANDARD_DEVIATION 96.8 • n=5 Participants
|
|
Index ulcer duration (months)
|
22.3 months
STANDARD_DEVIATION 18.5 • n=5 Participants
|
15.7 months
STANDARD_DEVIATION 12.0 • n=7 Participants
|
19 months
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Wound size at enrolment (cm^2)
|
19.4 cm^2
STANDARD_DEVIATION 14.9 • n=5 Participants
|
15.9 cm^2
STANDARD_DEVIATION 9.9 • n=7 Participants
|
17.8 cm^2
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Change in wound size during run-in phase (%)
|
-13.0 percentage change in wound area
STANDARD_DEVIATION 25.2 • n=5 Participants
|
-10.9 percentage change in wound area
STANDARD_DEVIATION 23.9 • n=7 Participants
|
-12.0 percentage change in wound area
STANDARD_DEVIATION 24.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 13Population: All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)
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.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Percentage Change in Wound Area
|
-39.2 percentage change in wound area
Standard Deviation 38.0
|
-46.6 percentage change in wound area
Standard Deviation 38.1
|
PRIMARY outcome
Timeframe: Week 5 to 13Population: As previous
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.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Actual Change in Wound Area
|
-5.3 cm2
Standard Deviation 5.5
|
-6.2 cm2
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Week 1 (start) and week 13 (exit)Population: All patients were analysed by ITT
On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values. CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)
|
0 units on a scale
Interval -1.0 to 1.0
|
-1 units on a scale
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: Weeks 5 to 13Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)
|
-5.27 scores on a scale
Standard Deviation 14.84
|
-14.35 scores on a scale
Standard Deviation 14.85
|
SECONDARY outcome
Timeframe: Weeks 5 to 13Population: All patients included; ITT.
Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Incidence of Wound Infection
|
2 Number of infections per patient
Interval 1.0 to 3.0
|
2 Number of infections per patient
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Week 5 to 13Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Number of Non-serious Adverse Events in Each Group
|
70 Number of non-serious AEs
|
59 Number of non-serious AEs
|
SECONDARY outcome
Timeframe: 90 days after time of healingPopulation: Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.
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.
Outcome measures
| Measure |
Standard of Care
n=1 Participants
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=2 Participants
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
Wound Recurrence Rate
|
1 Number of wounds remained healed
|
2 Number of wounds remained healed
|
Adverse Events
Standard of Care
NLFU and Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=19 participants at risk
Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
|
NLFU and Standard of Care
n=17 participants at risk
Non-contact low frequency ultrasound (NLFU) using 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.
|
|---|---|---|
|
General disorders
All adverse events
|
100.0%
19/19 • Study period of 13 weeks
Any undesirable clinical occurrence in a subject whether it is thought to be related to the NLFU or not. All subjects experiencing AEs were monitored until symptoms subside or until there is a satisfactory explanation for the changes observed. The nature of venous leg ulcers meant that AEs were common in both the SOC and NLFU groups
|
88.2%
15/17 • Study period of 13 weeks
Any undesirable clinical occurrence in a subject whether it is thought to be related to the NLFU or not. All subjects experiencing AEs were monitored until symptoms subside or until there is a satisfactory explanation for the changes observed. The nature of venous leg ulcers meant that AEs were common in both the SOC and NLFU groups
|
Additional Information
Dr Judith White
Cardiff and Vale University Health Board
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place