Trial Outcomes & Findings for Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (NCT NCT01549860)
NCT ID: NCT01549860
Last Updated: 2015-07-30
Results Overview
Compare between the treatment groups percent wound area reduction at four weeks of study treatment. H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size.
COMPLETED
NA
156 participants
4 weeks post baseline visit (randomization visit)
2015-07-30
Participant Flow
156 subjects were consented for the study, 112 subjects met the major inclusion/exclusion criteria (study cohort), 81 subject were randomized (reduced \<30% during run-in period).
Participant milestones
| Measure |
Standard Care (SC)
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Standard Care (SC)
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Standard Care (SC)
n=40 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
n=41 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=99 Participants
|
58.0 years
n=107 Participants
|
59.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
41 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
BMI
|
33.2 kg per meter squared
n=99 Participants
|
37.4 kg per meter squared
n=107 Participants
|
34.7 kg per meter squared
n=206 Participants
|
|
Wound Age at Randomization
|
8.9 months
n=99 Participants
|
10.3 months
n=107 Participants
|
10.3 months
n=206 Participants
|
|
Wound Area at Randomization
|
9.8 centimeters squared
n=99 Participants
|
12.4 centimeters squared
n=107 Participants
|
11.0 centimeters squared
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post baseline visit (randomization visit)Population: eligible subjects that were randomized
Compare between the treatment groups percent wound area reduction at four weeks of study treatment. H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size.
Outcome measures
| Measure |
Standard Care (SC)
n=40 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
n=41 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
|---|---|---|
|
Wound Area Mean Percent Reduction
|
45.8 percentage of mean area reduction
Standard Deviation 32.5
|
61.6 percentage of mean area reduction
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: 12 weeks post randomizationPopulation: Eligible subjects randomized
Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.
Outcome measures
| Measure |
Standard Care (SC)
n=40 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
n=41 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
|---|---|---|
|
Heal Rates
|
10 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 4 weeks post randomizationPopulation: Eligible Subjects Randomized
Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates "no pain" and the right end of line indicates "worst pain imaginable". VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone. H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC, Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons.
Outcome measures
| Measure |
Standard Care (SC)
n=40 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
|
SC + Mist Therapy
n=41 Participants
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
MIST Therapy: Non-contact low frequency ultrasound therapy
|
|---|---|---|
|
Change in Pain VAS Scores
4 Week post-randomizaton VAS Score
|
2.4 VAS pain level measured in centimeters
Interval 0.0 to 10.0
|
0.6 VAS pain level measured in centimeters
Interval 0.0 to 9.1
|
|
Change in Pain VAS Scores
Randomization (baseline) VAS Score
|
3.0 VAS pain level measured in centimeters
Interval 0.0 to 9.0
|
3.0 VAS pain level measured in centimeters
Interval 0.0 to 10.0
|
Adverse Events
Standard Care (SC)
SC + Mist Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place