Trial Outcomes & Findings for VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging (NCT NCT02680834)
NCT ID: NCT02680834
Last Updated: 2020-02-19
Results Overview
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Changes from Baseline to 16 weeks
Results posted on
2020-02-19
Participant Flow
All subjects participated in a two week run-in phase. The treatment included MLB which was worn 24 hours a day except during clinic visits. The run-in phase was intended to assess the subject's initial response to standard of care treatment using MLB before receiving treatment with the investigational device.
Participant milestones
| Measure |
Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
30
|
|
Overall Study
COMPLETED
|
15
|
27
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
Baseline characteristics by cohort
| Measure |
Dual Action Pneumatic Compression Device
n=26 Participants
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=30 Participants
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10 • n=5 Participants
|
64 years
STANDARD_DEVIATION 10 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes from Baseline to 16 weeksPopulation: \*Per Protocol Population (MITT patients who were randomized, received treatment, and did not exit the study early).
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
Outcome measures
| Measure |
Dual Action Pneumatic Compression Device
n=13 Participants
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=24 Participants
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Percentage of VLU Area Reduction
|
-83.8 percentage change
Standard Deviation 27.8
|
-70.5 percentage change
Standard Deviation 52.0
|
SECONDARY outcome
Timeframe: Changes from Baseline to 16 weeksPopulation: Per Protocol Population (Patients randomized who received treatment and had both Baseline and end of study measures).
The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present. All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life). In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
Outcome measures
| Measure |
Dual Action Pneumatic Compression Device
n=15 Participants
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=27 Participants
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Patient-Reported Quality of Life
|
-10.3 Change in total score
Standard Deviation 15.4
|
-1.7 Change in total score
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Changes from Baseline to 16 weeksPopulation: Per Protocol Population (Patients randomized who received treatment and had baseline and end of study measures).
Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
Outcome measures
| Measure |
Dual Action Pneumatic Compression Device
n=15 Participants
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=27 Participants
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Outpatient Costs
|
6748 Dollars
Standard Deviation 1308
|
8925 Dollars
Standard Deviation 2176
|
Adverse Events
Dual Action Pneumatic Compression Device
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Multi-layer Bandaging
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dual Action Pneumatic Compression Device
n=26 participants at risk
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=30 participants at risk
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Gastrointestinal disorders
GI Bleed
|
3.8%
1/26 • Number of events 1 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
0.00%
0/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
3.3%
1/30 • Number of events 1 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Nervous system disorders
Lumbar stenosis; spondylolisthesis
|
0.00%
0/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
3.3%
1/30 • Number of events 1 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
Other adverse events
| Measure |
Dual Action Pneumatic Compression Device
n=26 participants at risk
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs.
|
Multi-layer Bandaging
n=30 participants at risk
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs
|
|---|---|---|
|
Nervous system disorders
Pain/Discomfort
|
11.5%
3/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
20.0%
6/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
6.7%
2/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Infections and infestations
Infection
|
11.5%
3/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
13.3%
4/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
15.4%
4/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
16.7%
5/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.7%
2/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
0.00%
0/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
|
General disorders
Other
|
26.9%
7/26 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
10.0%
3/30 • 16 Weeks
An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multi-center publication, or if no multi-center publication is submitted for publication within 12 months after the conclusion or termination of the study at all sites, site may publish on your own site's data only. A draft of the manuscript must be submitted to Sponsor for review at least 45 days prior to submission for publication and 15 days for oral presentation. Sponsor shall respond to institution within 45 days of the receipt of draft.
- Publication restrictions are in place
Restriction type: OTHER