NCT01239160: ACE

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

Terminated NA Results posted Last updated 6 November 2020

What this trial tests

NA trial testing Flexitouch System in Lymphedema in 238 participants. Terminated before completion.

Timeline

2 November 2010

Primary endpoint
26 October 2011

27 June 2012

Quick facts

Lead sponsor	Tactile Medical
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	238
Start date	2 November 2010
Primary completion	26 October 2011
Estimated completion	27 June 2012
Sites	22 locations across United Kingdom, United States, Australia

Drugs / interventions tested

• Flexitouch System
• Hydroven FPR

Conditions studied

• Lymphedema — all drugs for Lymphedema →

Sponsor

Tactile Medical — full company profile →

Who can join

18 and older, any sex, with Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml Primary · Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

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.

Change Baseline to 1-Week

Group	Value	95% CI
Advanced PCD	-11.1	± 652.3
Simple PCD	75.3	± 678.0

Change Baseline to 4-Week

Group	Value	95% CI
Advanced PCD	7.4	± 636.3
Simple PCD	99.7	± 691.3

Change Baseline to 8-Week

Group	Value	95% CI
Advanced PCD	77.7	± 756.6
Simple PCD	167.9	± 760.7

Change Baseline to 12-Week

Group	Value	95% CI
Advanced PCD	102.1	± 724.5
Simple PCD	216.1	± 919.3

Limb Volume Change Baseline to 12 Weeks of Treatment - Percent Primary · Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

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.

Change Baseline to 1-Week

Group	Value	95% CI
Advanced PCD	-0.4	± 6.2
Simple PCD	0.9	± 5.8

Change Baseline to 4-Week

Group	Value	95% CI
Advanced PCD	-0.1	± 6.3
Simple PCD	0.9	± 5.9

Change Baseline to 8-Week

Group	Value	95% CI
Advanced PCD	0.2	± 7.4
Simple PCD	1.6	± 6.8

Change Baseline to 12-Week

Group	Value	95% CI
Advanced PCD	0.6	± 6.4
Simple PCD	2.2	± 7.6

Adverse Events - Totals Secondary · 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

Total Serious Adverse Events (SAE)

Group	Value	95% CI
Advanced PCD	3
Simple PCD	3

Device-Related SAE

Group	Value	95% CI
Advanced PCD	2
Simple PCD	0

Procedure-Related SAE

Group	Value	95% CI
Advanced PCD	0
Simple PCD	1

Unrelated SAE

Group	Value	95% CI
Advanced PCD	1
Simple PCD	2

Total Non-Serious Adverse Events (NSAE)

Group	Value	95% CI
Advanced PCD	34
Simple PCD	24

Device-Related NSAE

Group	Value	95% CI
Advanced PCD	13
Simple PCD	8

Procedure-Related NSAE

Group	Value	95% CI
Advanced PCD	12
Simple PCD	5

Unrelated NSAE

Group	Value	95% CI
Advanced PCD	9
Simple PCD	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events reported below were collected from Baseline through 24 week visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Advanced PCD

Serious: 3/64 (5%)

Deaths: 0/64

Simple PCD

Serious: 3/66 (5%)

Deaths: 0/66

Serious adverse events (6 terms)

Reaction	System	Advanced PCD	Simple PCD
Edema	Blood and lymphatic system disorders	—	—
Pain	Blood and lymphatic system disorders	—	—
Cancer	General disorders	—	—
Fractured legs	Musculoskeletal and connective tissue disorders	—	—
Discoloration of toes	Blood and lymphatic system disorders	—	—
Breathlessness	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Advanced PCD	Simple PCD
Pain/Itching	General disorders	—	—
Worsened swelling/Edema	Blood and lymphatic system disorders	—	—
Cellulitis/Infection	Infections and infestations	—	—
Vomiting/Diarrhea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Edema, Pain, Cancer, Fractured legs, Discoloration of toes, Breathlessness.

Data from ClinicalTrials.gov NCT01239160 adverse events section.

Sponsor's own description

The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition.

The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression.

This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.