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

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent, gradient, pneumatic compression device
Sponsored by
Calvary Hospital, Bronx, NY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring venous ulcer, secondary lymphedema, chronic lower leg ulceration

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calvary Hospital, Center for Curative and Palliative Wound Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPC plus standard compression

Standard compression alone

Arm Description

Outcomes

Primary Outcome Measures

Median Time to Wound Closure at 9 Months
Median number of days for complete healing in each treatment group

Secondary Outcome Measures

Full Information

First Posted
March 2, 2010
Last Updated
January 9, 2012
Sponsor
Calvary Hospital, Bronx, NY
Collaborators
RTS Family Foundation, New York State Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01079299
Brief Title
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Official Title
Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Calvary Hospital, Bronx, NY
Collaborators
RTS Family Foundation, New York State Department of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
venous ulcer, secondary lymphedema, chronic lower leg ulceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPC plus standard compression
Arm Type
Experimental
Arm Title
Standard compression alone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Intermittent, gradient, pneumatic compression device
Other Intervention Name(s)
Bio 4000 (Bio Compression Inc, Moonachie,NJ)
Intervention Description
lymphedema pump provides external compression in a segmental,gradient fashion
Primary Outcome Measure Information:
Title
Median Time to Wound Closure at 9 Months
Description
Median number of days for complete healing in each treatment group
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Calvary Hospital, Center for Curative and Palliative Wound Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

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

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