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Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE)

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ClinicalTrials.gov Identifier: NCT01239160
Recruitment Status : Terminated (Futility and underpowering of endpoint data)
First Posted : November 11, 2010
Results First Posted : October 14, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Lymphedema
Interventions Device: Flexitouch System
Device: Hydroven FPR
Enrollment 238
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Advanced PCD Simple PCD Treatment Not Assigned
Hide Arm/Group Description

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

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.

Consented, but did withdrawn prior to being randomized into one of the treatment groups.
Period Title: Overall Study
Started [1] 114 114 10
Completed 89 95 0
Not Completed 25 19 10
Reason Not Completed
Lost to Follow-up             3             5             0
Withdrawal by Subject             17             6             2
Physician Decision             5             7             2
Early Termination Due to Study Closure             0             1             6
[1]
Of the 238 patients "started", 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis reported below. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Arm/Group Title Advanced PCD Simple PCD Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 64 66 130
Hide Baseline Analysis Population Description
Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
< 65 years
47
  73.4%
43
  65.2%
90
  69.2%
≥ 65 years
17
  26.6%
23
  34.8%
40
  30.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Female
47
  73.4%
52
  78.8%
99
  76.2%
Male
17
  26.6%
14
  21.2%
31
  23.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Hispanic or Latino
2
   3.1%
1
   1.5%
3
   2.3%
Not Hispanic or Latino
60
  93.8%
64
  97.0%
124
  95.4%
Unknown or Not Reported
2
   3.1%
1
   1.5%
3
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.6%
3
   4.5%
4
   3.1%
White
59
  92.2%
61
  92.4%
120
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   6.3%
2
   3.0%
6
   4.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
United States 13 12 25
United Kingdom 51 54 105
Etiology of Lymphedema  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Primary
34
  53.1%
34
  51.5%
68
  52.3%
Secondary
30
  46.9%
32
  48.5%
62
  47.7%
Severity of Lymphedema   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Late Stage II
59
  92.2%
61
  92.4%
120
  92.3%
Stage III
5
   7.8%
5
   7.6%
10
   7.7%
[1]
Measure Description:

Late stage 2 is defined as prolonged swelling spontaneously irreversible, pitting becomes difficult to produce, presence of fibrosis, history of infection, the difference in circumference is between 4 and 6 cm (at a single point of measurement).

Stage 3, considered worse than stage 2, is defined as presence of skin folds, severe tissue induration (fibrosis and sclerosis), skin changes (papillomas, hyperkeratosis, lymph cysts, fistulas), the difference in circumference is between greater than 6 cm (at a single point of measurement).

Hosiery Used  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Yes
47
  73.4%
48
  72.7%
95
  73.1%
No
17
  26.6%
18
  27.3%
35
  26.9%
1.Primary Outcome
Title Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml
Hide Description 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.
Time Frame Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Advanced PCD Simple PCD
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: ml
Change Baseline to 1-Week Number Analyzed 60 participants 64 participants
-11.1  (652.3) 75.3  (678.0)
Change Baseline to 4-Week Number Analyzed 61 participants 62 participants
7.4  (636.3) 99.7  (691.3)
Change Baseline to 8-Week Number Analyzed 57 participants 57 participants
77.7  (756.6) 167.9  (760.7)
Change Baseline to 12-Week Number Analyzed 54 participants 57 participants
102.1  (724.5) 216.1  (919.3)
2.Primary Outcome
Title Limb Volume Change Baseline to 12 Weeks of Treatment - Percent
Hide Description 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.
Time Frame Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Advanced PCD Simple PCD
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 64 66
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
Change Baseline to 1-Week Number Analyzed 60 participants 64 participants
-0.4  (6.2) 0.9  (5.8)
Change Baseline to 4-Week Number Analyzed 61 participants 62 participants
-0.1  (6.3) 0.9  (5.9)
Change Baseline to 8-Week Number Analyzed 57 participants 57 participants
0.2  (7.4) 1.6  (6.8)
Change Baseline to 12-Week Number Analyzed 54 participants 57 participants
0.6  (6.4) 2.2  (7.6)
3.Secondary Outcome
Title Adverse Events - Totals
Hide Description Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial
Time Frame Up to 24 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Advanced PCD Simple PCD
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 64 66
Measure Type: Number
Unit of Measure: number of events
Total Serious Adverse Events (SAE) 3 3
Device-Related SAE 2 0
Procedure-Related SAE 0 1
Unrelated SAE 1 2
Total Non-Serious Adverse Events (NSAE) 34 24
Device-Related NSAE 13 8
Procedure-Related NSAE 12 5
Unrelated NSAE 9 11
Time Frame Adverse events reported below were collected from Baseline through 24 week visit.
Adverse Event Reporting Description 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.
 
Arm/Group Title Advanced PCD Simple PCD
Hide Arm/Group Description

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

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.

All-Cause Mortality
Advanced PCD Simple PCD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/66 (0.00%)    
Hide Serious Adverse Events
Advanced PCD Simple PCD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/64 (4.69%)      3/66 (4.55%)    
Blood and lymphatic system disorders     
Edema  [1]  1/64 (1.56%)  1 0/66 (0.00%)  0
Pain  [2]  1/64 (1.56%)  1 0/66 (0.00%)  0
Discoloration of toes   0/64 (0.00%)  0 1/66 (1.52%)  1
General disorders     
Cancer  [3]  0/64 (0.00%)  0 1/66 (1.52%)  1
Musculoskeletal and connective tissue disorders     
Fractured legs  [4]  0/64 (0.00%)  0 1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders     
Breathlessness  [5]  1/64 (1.56%)  1 0/66 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Study leg became markedly swollen (no cellulitis).
[2]
Extreme shooting pain followed by swelling and hardness of the leg.
[3]
New diagnosis of lung cancer.
[4]
Fractured legs from motor vehicle accident.
[5]
Breathlessness and dizziness.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Advanced PCD Simple PCD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/64 (39.06%)      15/66 (22.73%)    
Blood and lymphatic system disorders     
Worsened swelling/Edema   6/64 (9.38%)  6 4/66 (6.06%)  4
Gastrointestinal disorders     
Vomiting/Diarrhea   4/64 (6.25%)  4 0/66 (0.00%)  0
General disorders     
Pain/Itching   9/64 (14.06%)  9 7/66 (10.61%)  7
Infections and infestations     
Cellulitis/Infection   6/64 (9.38%)  6 4/66 (6.06%)  5
Indicates events were collected by systematic assessment
Early termination DSMB recommendation on 23Jan2012 due to underpowered endpoint in 26Oct2011 dataset. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Tactile Medical
Phone: 612-540-5267
EMail: astone@tactilemedical.com
Layout table for additonal information
Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT01239160    
Other Study ID Numbers: Flexitouch 1010
First Submitted: November 10, 2010
First Posted: November 11, 2010
Results First Submitted: August 24, 2020
Results First Posted: October 14, 2020
Last Update Posted: November 6, 2020