Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema

January 9, 2012 updated by: Calvary Hospital, Bronx, NY

Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency

This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Calvary Hospital, Center for Curative and Palliative Wound Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with secondary lymphedema
  • Presence of a venous ulcer that has not healed in more than 6 months
  • Localized wound pain greater than 3 with VAS
  • Ulcer must be on lower leg (below knee)
  • Ulcer must be of venous etiology
  • CVI proven by duplex studies
  • Subject must have adequate arterial blood flow (ABI > 0.70)
  • Subject must be able to tolerate compression bandages
  • Subject must be ambulatory
  • Capable of understanding consent process

Exclusion Criteria:

  • Wound infection
  • Ulcer of non-venous etiology
  • Ulcer on toes or plantar surface of the foot
  • Subject taking any medication that in the opinion of the investigator affects wound healing
  • Alcohol or drug abuse
  • Active deep venous thrombosis (DVT)
  • Subject has a cancer diagnosis
  • Diabetic with hemoglobin A1C>12
  • Arterial insufficiency ABI<0.70
  • Subject is not capable of walking (wheelchair-bound or bed-bound)
  • Subject currently enrolled in another clinical trial
  • Moderate to severe congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IPC plus standard compression
Device: Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Names:
  • Bio 4000 (Bio Compression Inc, Moonachie,NJ)
ACTIVE_COMPARATOR: Standard compression alone
Device: Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Names:
  • Bio 4000 (Bio Compression Inc, Moonachie,NJ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Wound Closure at 9 Months
Time Frame: 9 months
Median number of days for complete healing in each treatment group
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calvary Hospital, Bronx, NY

Collaborators

New York State Department of Health
RTS Family Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (ESTIMATE)

March 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-VU-0308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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