Trial Outcomes & Findings for Imaging Biomarkers of Lymphatic Dysfunction (NCT NCT03760744)
NCT ID: NCT03760744
Last Updated: 2025-10-16
Results Overview
BIS is a noninvasive technology measuring the resistance and reactance of tissue across multiple electrical frequencies using the Impedimed U400 device. By distinguishing ICF from ECF, BIS allows sensitive detection of ECF accumulation, a hallmark of lymphedema. Impedimed's proprietary calculations convert impedance ratios of limbs (involved vs unaffected) into a single output known as LDEX (lymphedema index) with an output normal range of -10 to +10. In situations of overt signs of lymphedema, the LDEX value could be up to 120. This single output value (LDEX) is used in lymphedema research and clinical care to monitor lymphedema progress and response to lymphedema therapy. The LDEX outcome in this study represents the change in LDEX value of the arms from study baseline and at 6-8 weeks following the completion of therapy where a negative value shows a positive response from the therapy intervention by indicating a reduction in the LDEX value.
COMPLETED
NA
18 participants
At baseline and at 6-8 weeks following the completion of therapy
2025-10-16
Participant Flow
Participant milestones
| Measure |
CDT Alone First, Then CDT With Negative Pressure
A total of 9 therapy visits (75minutes duration) of CDT alone without LymphaTouch was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT with Negative Pressure.
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
CDT With Negative Pressure First, Then CDT Alone
A total of 9 therapy visits (75minutes duration) of CDT alone with LymphaTouch negative pressure was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT without Negative Pressure.
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
CDT Alone First, Then CDT With Negative Pressure
A total of 9 therapy visits (75minutes duration) of CDT alone without LymphaTouch was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT with Negative Pressure.
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
CDT With Negative Pressure First, Then CDT Alone
A total of 9 therapy visits (75minutes duration) of CDT alone with LymphaTouch negative pressure was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT without Negative Pressure.
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Imaging Biomarkers of Lymphatic Dysfunction
Baseline characteristics by cohort
| Measure |
CDT Alone First, Then CDT With Negative Pressure
n=6 Participants
A total of 9 therapy visits (75minutes duration) of CDT alone without LymphaTouch was administered for 6 weeks. After a six month washout period, participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT with Negative Pressure.
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
CDT With Negative Pressure First, Then CDT Alone
n=9 Participants
A total of 9 therapy visits (75minutes duration) of CDT with LymphaTouch Negative Pressure was administered for 6 weeks. After a six month washout period, participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT Alone, without Negative Pressure.
CDT Alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance.
CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
n=5 Participants
|
51.5 years
n=7 Participants
|
50.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 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
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at 6-8 weeks following the completion of therapyBIS is a noninvasive technology measuring the resistance and reactance of tissue across multiple electrical frequencies using the Impedimed U400 device. By distinguishing ICF from ECF, BIS allows sensitive detection of ECF accumulation, a hallmark of lymphedema. Impedimed's proprietary calculations convert impedance ratios of limbs (involved vs unaffected) into a single output known as LDEX (lymphedema index) with an output normal range of -10 to +10. In situations of overt signs of lymphedema, the LDEX value could be up to 120. This single output value (LDEX) is used in lymphedema research and clinical care to monitor lymphedema progress and response to lymphedema therapy. The LDEX outcome in this study represents the change in LDEX value of the arms from study baseline and at 6-8 weeks following the completion of therapy where a negative value shows a positive response from the therapy intervention by indicating a reduction in the LDEX value.
Outcome measures
| Measure |
CDT Alone
n=30 affected vs unaffected limbs
CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
|
CDT With Negative Pressure
n=30 affected vs unaffected limbs
CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance
|
|---|---|---|
|
Assessing a Change in Bioimpedance Spectroscopy (BIS)
|
1.3 Change of score on a scale
Standard Deviation 8
|
1.8 Change of score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy (post-intervention)The Patient Specific Functional Scale (PSFS) was developed as a self-report outcome measure of function that could be used in participants with varying levels of independence. Each participant chose a set of three daily activities and rated the level of ease and comfort with which they could complete them pre and post each intervention. Rating scale starts at 0 (unable to perform activity) and goes to goes up to 10 (able to perform activity at the same level as before injury or problem). The closer to 10, the more favorable the number is.
Outcome measures
| Measure |
CDT Alone
n=15 Participants
CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
|
CDT With Negative Pressure
n=15 Participants
CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance
|
|---|---|---|
|
Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS)
At baseline (Pre-Intervention)
|
5.1 PSFS score
Standard Deviation 2.0
|
5.0 PSFS score
Standard Deviation 1.8
|
|
Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS)
at 6-8 weeks following the completion of each therapy (Post-Intervention)
|
6.6 PSFS score
Standard Deviation 2.5
|
7.0 PSFS score
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy ([post intervention )Population: While participants started in different groups, all 15 analyzed participants went through both arms of the study after a washout period. This number represents all participants who completed both arms of the study.
TDC measures the skin-to-fat water content in tissues. The location was chosen given the propensity of swelling and discomfort in the area for participant population. This measurement compares the TDC value in the affected limb versus the unaffected limb, therefore the closer the TDC measurement difference is to zero, the more favorable the value is.
Outcome measures
| Measure |
CDT Alone
n=30 affected limb versus the unaffected limb
CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
|
CDT With Negative Pressure
n=30 affected limb versus the unaffected limb
CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
CDT with Negative Pressure: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance
|
|---|---|---|
|
Tissue Dielectric Constant (TDC) Measurement Difference Above the Elbow
At Baseline (Pre-Intervention)
|
9.8 TDC % change
Standard Deviation 10.8
|
9.4 TDC % change
Standard Deviation 9.7
|
|
Tissue Dielectric Constant (TDC) Measurement Difference Above the Elbow
6-8 weeks following the completion of each therapy (Post-Intervention)
|
8.9 TDC % change
Standard Deviation 9.5
|
4.8 TDC % change
Standard Deviation 5.8
|
Adverse Events
CDT Alone
CDT With Negative Pressure
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