Trial Outcomes & Findings for Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (NCT NCT01239160)

Last Updated: 2020-11-06

Results Overview

Limb volume in ml as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.

Recruitment status

TERMINATED

Study phase

Target enrollment

238 participants

Primary outcome timeframe

Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Results posted on

2020-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Advanced PCD The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.	Treatment Not Assigned Consented, but did withdrawn prior to being randomized into one of the treatment groups.
Overall Study STARTED	114	114	10
Overall Study COMPLETED	89	95	0
Overall Study NOT COMPLETED	25	19	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Advanced PCD The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.	Treatment Not Assigned Consented, but did withdrawn prior to being randomized into one of the treatment groups.
Overall Study Lost to Follow-up	3	5	0
Overall Study Withdrawal by Subject	17	6	2
Overall Study Physician Decision	5	7	2
Overall Study Early Termination Due to Study Closure	0	1	6

Baseline Characteristics

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Advanced PCD n=64 Participants The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day.	Simple PCD n=66 Participants The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.	Total n=130 Participants Total of all reporting groups
Age, Customized < 65 years	47 Participants n=93 Participants	43 Participants n=4 Participants	90 Participants n=27 Participants
Age, Customized ≥ 65 years	17 Participants n=93 Participants	23 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Female	47 Participants n=93 Participants	52 Participants n=4 Participants	99 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	14 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=93 Participants	64 Participants n=4 Participants	124 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	59 Participants n=93 Participants	61 Participants n=4 Participants	120 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	12 participants n=4 Participants	25 participants n=27 Participants
Region of Enrollment United Kingdom	51 participants n=93 Participants	54 participants n=4 Participants	105 participants n=27 Participants
Etiology of Lymphedema Primary	34 Participants n=93 Participants	34 Participants n=4 Participants	68 Participants n=27 Participants
Etiology of Lymphedema Secondary	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Severity of Lymphedema Late Stage II	59 Participants n=93 Participants	61 Participants n=4 Participants	120 Participants n=27 Participants
Severity of Lymphedema Stage III	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Hosiery Used Yes	47 Participants n=93 Participants	48 Participants n=4 Participants	95 Participants n=27 Participants
Hosiery Used No	17 Participants n=93 Participants	18 Participants n=4 Participants	35 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Population: Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed a visit or who did not complete the assessment at the visit were excluded.

Outcome measures

Outcome measures
Measure	Advanced PCD n=64 Participants The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD n=66 Participants The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml Change Baseline to 1-Week	-11.1 ml Standard Deviation 652.3	75.3 ml Standard Deviation 678.0
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml Change Baseline to 4-Week	7.4 ml Standard Deviation 636.3	99.7 ml Standard Deviation 691.3
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml Change Baseline to 8-Week	77.7 ml Standard Deviation 756.6	167.9 ml Standard Deviation 760.7
Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml Change Baseline to 12-Week	102.1 ml Standard Deviation 724.5	216.1 ml Standard Deviation 919.3

PRIMARY outcome

Timeframe: Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Population: Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed visits or who did not complete the assessment at the visit were excluded.

Limb volume (percent change from baseline) as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.

Outcome measures

Outcome measures
Measure	Advanced PCD n=64 Participants The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD n=66 Participants The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent Change Baseline to 1-Week	-0.4 percent change from baseline Standard Deviation 6.2	0.9 percent change from baseline Standard Deviation 5.8
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent Change Baseline to 4-Week	-0.1 percent change from baseline Standard Deviation 6.3	0.9 percent change from baseline Standard Deviation 5.9
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent Change Baseline to 8-Week	0.2 percent change from baseline Standard Deviation 7.4	1.6 percent change from baseline Standard Deviation 6.8
Limb Volume Change Baseline to 12 Weeks of Treatment - Percent Change Baseline to 12-Week	0.6 percent change from baseline Standard Deviation 6.4	2.2 percent change from baseline Standard Deviation 7.6

SECONDARY outcome

Timeframe: Up to 24 weeks of treatment

Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial

Outcome measures

Outcome measures
Measure	Advanced PCD n=64 Participants The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD n=66 Participants The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
Adverse Events - Totals Unrelated NSAE	9 number of events	11 number of events
Adverse Events - Totals Total Serious Adverse Events (SAE)	3 number of events	3 number of events
Adverse Events - Totals Device-Related SAE	2 number of events	0 number of events
Adverse Events - Totals Procedure-Related SAE	0 number of events	1 number of events
Adverse Events - Totals Unrelated SAE	1 number of events	2 number of events
Adverse Events - Totals Total Non-Serious Adverse Events (NSAE)	34 number of events	24 number of events
Adverse Events - Totals Device-Related NSAE	13 number of events	8 number of events
Adverse Events - Totals Procedure-Related NSAE	12 number of events	5 number of events

Adverse Events

Advanced PCD

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Simple PCD

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Advanced PCD n=64 participants at risk The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD n=66 participants at risk The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
Blood and lymphatic system disorders Edema	1.6% 1/64 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	0.00% 0/66 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Blood and lymphatic system disorders Pain	1.6% 1/64 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	0.00% 0/66 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
General disorders Cancer	0.00% 0/64 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	1.5% 1/66 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Musculoskeletal and connective tissue disorders Fractured legs	0.00% 0/64 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	1.5% 1/66 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Blood and lymphatic system disorders Discoloration of toes	0.00% 0/64 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	1.5% 1/66 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Respiratory, thoracic and mediastinal disorders Breathlessness	1.6% 1/64 • Number of events 1 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	0.00% 0/66 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.

Other adverse events

Other adverse events
Measure	Advanced PCD n=64 participants at risk The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day	Simple PCD n=66 participants at risk The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
Blood and lymphatic system disorders Worsened swelling/Edema	9.4% 6/64 • Number of events 6 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	6.1% 4/66 • Number of events 4 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Gastrointestinal disorders Vomiting/Diarrhea	6.2% 4/64 • Number of events 4 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	0.00% 0/66 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
General disorders Pain/Itching	14.1% 9/64 • Number of events 9 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	10.6% 7/66 • Number of events 7 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Infections and infestations Cellulitis/Infection	9.4% 6/64 • Number of events 6 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.	6.1% 4/66 • Number of events 5 • Adverse events reported below were collected from Baseline through 24 week visit. Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.

Additional Information

Director of Clinical Research

Tactile Medical

Phone: 612-540-5267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60