Trial Outcomes & Findings for Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling) (NCT NCT04213989)
NCT ID: NCT04213989
Last Updated: 2022-08-23
Results Overview
Tape measurements along both legs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Changes between Screening and 3-4 weeks will be assessed
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Conservative Care
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Conservative Care
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
Baseline characteristics by cohort
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
BMI
|
37.0 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
35.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=7 Participants
|
36.5 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedTape measurements along both legs
Outcome measures
| Measure |
Conservative Care
n=28 Legs
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=24 Legs
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Change in Circumferential Measurements Over Time
Thigh
|
-1.7 cm
Interval -2.7 to -0.8
|
-3.0 cm
Interval -4.1 to -2.0
|
|
Change in Circumferential Measurements Over Time
Hip
|
-0.4 cm
Interval -4.7 to 3.9
|
3.2 cm
Interval -1.5 to 7.9
|
|
Change in Circumferential Measurements Over Time
Waist
|
-2.4 cm
Interval -4.0 to -0.7
|
-2.3 cm
Interval -4.1 to -0.5
|
|
Change in Circumferential Measurements Over Time
Ankle
|
-0.5 cm
Interval -0.9 to -0.1
|
-1.0 cm
Interval -1.4 to -0.5
|
|
Change in Circumferential Measurements Over Time
Calf
|
-1.3 cm
Interval -1.9 to -0.6
|
-2.0 cm
Interval -2.7 to -1.2
|
|
Change in Circumferential Measurements Over Time
Knee
|
-2.4 cm
Interval -3.7 to -1.2
|
-4.7 cm
Interval -6.0 to -3.4
|
PRIMARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedRAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Patient-Reported Quality of Life
Emotional wellbeing
|
2.8 score on a scale
Interval -1.9 to 7.6
|
-1.0 score on a scale
Interval -6.1 to 4.2
|
|
Patient-Reported Quality of Life
Role limitations due to emotional problems
|
-10.9 score on a scale
Interval -26.7 to 4.8
|
-2.2 score on a scale
Interval -18.5 to 14.3
|
|
Patient-Reported Quality of Life
Social functioning
|
9.9 score on a scale
Interval -0.2 to 20.0
|
-2.2 score on a scale
Interval -13.1 to 8.7
|
|
Patient-Reported Quality of Life
Pain
|
4.5 score on a scale
Interval -2.1 to 11.0
|
10.2 score on a scale
Interval 3.1 to 17.3
|
|
Patient-Reported Quality of Life
General health
|
-2.7 score on a scale
Interval -10.9 to 5.5
|
1.3 score on a scale
Interval -7.6 to 10.2
|
|
Patient-Reported Quality of Life
Physical functioning
|
2.6 score on a scale
Interval -3.7 to 8.9
|
5.3 score on a scale
Interval -1.5 to 12.1
|
|
Patient-Reported Quality of Life
Role limitations due to physical functioning
|
-1.2 score on a scale
Interval -21.9 to 19.5
|
1.4 score on a scale
Interval -20.9 to 23.8
|
|
Patient-Reported Quality of Life
Energy/fatigue
|
4.8 score on a scale
Interval -2.2 to 11.8
|
0.7 score on a scale
Interval -6.9 to 8.3
|
PRIMARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedPROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Patient-Reported Pain Interference
|
-1.4 score on a scale
Interval -4.8 to 2.1
|
-3.0 score on a scale
Interval -6.8 to 0.7
|
PRIMARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedWong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Patient-Reported Pain
|
-0.8 score on a scale
Interval -1.7 to 0.0
|
-0.8 score on a scale
Interval -1.8 to 0.1
|
PRIMARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedNRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Pain-Left Leg
|
-0.3 score on a scale
Interval -1.4 to 0.9
|
-1.4 score on a scale
Interval -2.6 to -0.1
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Fatigue-Left Leg
|
-1.4 score on a scale
Interval -2.5 to -0.4
|
-0.6 score on a scale
Interval -1.7 to 0.5
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Heaviness-Right Leg
|
-0.8 score on a scale
Interval -1.7 to 0.1
|
-0.5 score on a scale
Interval -1.5 to 0.4
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Pain-Right Leg
|
-0.1 score on a scale
Interval -1.2 to 1.1
|
-0.5 score on a scale
Interval -1.8 to 0.8
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Tightness-Right Leg
|
-0.9 score on a scale
Interval -2.0 to 0.2
|
-1.6 score on a scale
Interval -2.7 to -0.4
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Swelling-Left Leg
|
-0.5 score on a scale
Interval -1.7 to 0.8
|
-0.2 score on a scale
Interval -1.6 to 1.2
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Heaviness-Left Leg
|
-0.9 score on a scale
Interval -2.0 to 0.3
|
-1.0 score on a scale
Interval -2.2 to 0.3
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Tenderness-Left Leg
|
-0.6 score on a scale
Interval -1.7 to 0.6
|
-0.2 score on a scale
Interval -1.4 to 1.0
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Tightness-Left Leg
|
-1.2 score on a scale
Interval -2.1 to -0.2
|
-1.8 score on a scale
Interval -2.9 to -0.8
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Swelling-Right Leg
|
-0.7 score on a scale
Interval -1.8 to 0.4
|
0.1 score on a scale
Interval -1.2 to 1.3
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Fatigue-Right Leg
|
-1.8 score on a scale
Interval -2.9 to -0.7
|
-0.3 score on a scale
Interval -0.5 to 0.8
|
|
Patient-Reported Symptoms of Lipo-Lymphedema
Tenderness-Right Leg
|
-0.1 score on a scale
Interval -1.2 to 1.0
|
0.1 score on a scale
Interval -1.1 to 1.3
|
SECONDARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedPROMIS Item Bank v2.0 - Mobility is a 15-item survey that focuses on activities of physical mobility such as getting out of bed or a chair to activities such as running. All items are scored so that a high score is associated with more mobility (a more favorable health state). In addition, each item is scored on a 5 to 1 range so that the highest and lowest possible scores are 75 and 15, respectively.
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Patient-Reported Mobility
|
2.9 score on a scale
Interval 0.4 to 5.4
|
-0.6 score on a scale
Interval -3.4 to 2.1
|
SECONDARY outcome
Timeframe: Changes between Screening and 3-4 weeks will be assessedPopulation: Each participant underwent circumferential measurement at baseline and at follow-up. Patients were measured at 4 sites on each leg (narrowest part of the ankle, largest part of the calf, top of knee cap, and thickest part of the upper thigh), the widest part of the hips and the widest part of the waist.
InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios
Outcome measures
| Measure |
Conservative Care
n=14 Participants
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
Flexitouch Plus and Conservative Care
n=12 Participants
Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
|
|---|---|---|
|
Change in Bioimpedance Measurements Over Time
Whole body
|
-0.001 ohms
Interval -0.004 to 0.001
|
-0.002 ohms
Interval -0.005 to 0.0
|
|
Change in Bioimpedance Measurements Over Time
Trunk
|
-0.001 ohms
Interval -0.003 to 0.001
|
-0.002 ohms
Interval -0.005 to 0.0
|
|
Change in Bioimpedance Measurements Over Time
Arms
|
0.000 ohms
Interval -0.001 to 0.001
|
0.000 ohms
Interval -0.001 to 0.001
|
|
Change in Bioimpedance Measurements Over Time
Legs
|
-0.003 ohms
Interval -0.005 to 0.0
|
-0.004 ohms
Interval -0.006 to -0.002
|
Adverse Events
Conservative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flexitouch Plus and Conservative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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