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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

Tracking Information
First Submitted Date  ICMJE November 10, 2010
First Posted Date  ICMJE November 11, 2010
Results First Submitted Date  ICMJE August 24, 2020
Results First Posted Date  ICMJE October 14, 2020
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE November 2, 2010
Actual Primary Completion Date October 26, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml [ Time Frame: 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.
  • Limb Volume Change Baseline to 12 Weeks of Treatment - Percent [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2010)
limb volume change [ Time Frame: weeks one, four, eight, twelve and 24 ]
Limb volume as assessed by tape measure at 4 cm intervals up the limb. Volume calculated by assuming a truncated cone for each section of the limb.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
Adverse Events - Totals [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2010)
Adverse events [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Official Title  ICMJE At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)
Brief Summary

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.

Detailed Description

This is a Multicentre, prospective, single (assessor) blind randomised study. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs with an advanced PCD compared to a simple PCD in patients with lower limb lymphoedema. The main outcome is the percentage volume reduction of the affected limb at end of treatment compared to baseline.

Secondary objectives of the study are Assessment of safety Quality of life Health economic parameters

In total 262 patients with leg lymphoedema will be enrolled into the study. Patients eligible for the study are those who suffer from late stage II and stage III according to the International Society of Lymphology lymphoedema staging. Lymphoedematous legs can be of primary or secondary origin and uni or bilaterally affected. Medical history will be taken at baseline.

Patients will be taught how to use the device they have been randomised to. Visits will then take place at weeks 1,4,8,12 and 24 weeks. The device will be used for up to 60 minutes each day on the trial limb. At each visit sequential circumferences of the affected and unaffected limbs will be measured with a tape measure.

All adverse events will be documented. At beginning and end of study quality of life questionnaires and health economic information will be completed by the patients.

At the Derby site assessment of tissue quality will be made using ultrasound and moisture meter to assess tissue fluid.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lymphedema
Intervention  ICMJE
  • Device: 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
  • Device: 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.
Study Arms  ICMJE
  • Experimental: Advanced PCD
    The use of an advanced PCD device to reduce and maintain limb volume
    Intervention: Device: Flexitouch System
  • Active Comparator: Simple PCD
    The use of the Simple PCD is to reduce and maintain limb volume
    Intervention: Device: Hydroven FPR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2020)
238
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2010)
262
Actual Study Completion Date  ICMJE June 27, 2012
Actual Primary Completion Date October 26, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be ≥ 18 years old or legal age in host country.
  • Subjects must have a diagnosis of primary or secondary late Stage 2 or 3 unilateral or bilateral lower extremity lymphoedema.
  • At time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable.
  • If subjects were treated in a clinic setting for lymphoedema (Phase 1 treatment) they must be at least 3 months post completion of their acute care.

Exclusion Criteria:

  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.
  • Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.
  • Diagnosis of acute thrombophlebitis (in last 2 months)
  • Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower.
  • Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
  • Diagnosis of pulmonary edema
  • Diagnosis of congestive heart failure (uncontrolled)
  • Diagnosis of chronic kidney disease with a Glomerular Filtration Rate (GFR) of less than 30 mls per minute.
  • Patients with poorly controlled asthma (i.e. those with severe persistent symptoms throughout the day, night time awakenings several times per week, use of a beta2 agonist inhaler several times per day and those whose normal activity is extremely limited).
  • Pregnancy
  • Any condition where increased venous and lymphatic return is undesirable
  • Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
  • Currently participating in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239160
Other Study ID Numbers  ICMJE Flexitouch 1010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tactile Medical
Study Sponsor  ICMJE Tactile Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christine J Moffatt, RN PhD Nottingham Trent University
Study Director: Vaughan Keeley, MD Derby Hospitals NHS Trust
Principal Investigator: Margaret Sneddon, RGN University of Glasgow
Principal Investigator: Peter J Franks, PhD Tactile Medical
PRS Account Tactile Medical
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP