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Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema (PCD-LYMPH)

Primary Purpose

Lymphedema

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise, Elevation, and Compression Garment
E0650 PCD with non-sequential waveform
E0651 PCD with sequential, non-gradient waveform
E0652 PCD with sequential, gradient waveform
E0652 PCD with peristaltic pulse waveform
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, Breast Cancer, Upper Extremity, Arm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with acquired lymphedema of the arm.

Exclusion Criteria:

  • Refusal of consent
  • Unlikely compliance with the research protocol
  • Acute upper extremity DVT

Sites / Locations

  • Children's Hospital Boston at Waltham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Exercise, Elevation, and Garment Compression

Pneumatic Compression Device (B)

Pneumatic Compression Device (C)

Pneumatic Compression Device (D)

Pneumatic Compression Device (E)

Outcomes

Primary Outcome Measures

Arm Volume

Secondary Outcome Measures

Infection (cellulitis)
Quality of Life Survey

Full Information

First Posted
August 3, 2009
Last Updated
January 30, 2014
Sponsor
Boston Children's Hospital
Collaborators
NormaTec Industries LP
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1. Study Identification

Unique Protocol Identification Number
NCT00951067
Brief Title
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
Acronym
PCD-LYMPH
Official Title
Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not available to continue with study.
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Children's Hospital
Collaborators
NormaTec Industries LP

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine how well different treatments for acquired lymphedema work. The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
Detailed Description
This study will compare 5 non-invasive lymphedema treatments. Patients will be assigned to either: - A combination of arm exercises, arm elevation, and wearing of a compression garment every day OR - One of four possible pneumatic compression devices for just two hours every day. Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken. None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home. The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Lymphedema, Breast Cancer, Upper Extremity, Arm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Exercise, Elevation, and Garment Compression
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Pneumatic Compression Device (B)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Pneumatic Compression Device (C)
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Pneumatic Compression Device (D)
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Pneumatic Compression Device (E)
Intervention Type
Other
Intervention Name(s)
Exercise, Elevation, and Compression Garment
Intervention Description
Patients will be asked to daily: exercise elevate arm wear an arm compression garment
Intervention Type
Device
Intervention Name(s)
E0650 PCD with non-sequential waveform
Other Intervention Name(s)
Brand: Huntleigh Flowtron Hydroven™ 3
Intervention Description
Use of an E0650 PCD with non-sequential waveform for two hours every day.
Intervention Type
Device
Intervention Name(s)
E0651 PCD with sequential, non-gradient waveform
Other Intervention Name(s)
Brand: Petite Basic System (Model 701A) Lympha Press
Intervention Description
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
Intervention Type
Device
Intervention Name(s)
E0652 PCD with sequential, gradient waveform
Other Intervention Name(s)
Brand: Bio Compression Sequential Circulator 3008
Intervention Description
Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
Intervention Type
Device
Intervention Name(s)
E0652 PCD with peristaltic pulse waveform
Other Intervention Name(s)
NormaTec brand
Intervention Description
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
Primary Outcome Measure Information:
Title
Arm Volume
Time Frame
Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Secondary Outcome Measure Information:
Title
Infection (cellulitis)
Time Frame
Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Title
Quality of Life Survey
Time Frame
Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with acquired lymphedema of the arm. Exclusion Criteria: Refusal of consent Unlikely compliance with the research protocol Acute upper extremity DVT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arin K Greene, MD, MMSc
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston at Waltham
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States

12. IPD Sharing Statement

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Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

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