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

This study has been completed.
Sponsor:
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01079299
First received: March 2, 2010
Last updated: January 9, 2012
Last verified: August 2010
History of Changes
  Purpose

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).


Condition Intervention
Lymphedema
 Device: Intermittent, gradient, pneumatic compression device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Further study details as provided by Calvary Hospital, Bronx, NY:

Primary Outcome Measures:
  • Median Time to Wound Closure at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Median number of days for complete healing in each treatment group


Enrollment: 52
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPC plus standard compression Device: Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Name: 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 Name: Bio 4000 (Bio Compression Inc, Moonachie,NJ)

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079299

Locations
United States, New York
Calvary Hospital, Center for Curative and Palliative Wound Care
Bronx, New York, United States, 10461
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
RTS Family Foundation
New York State Department of Health
  More Information

No publications provided

Responsible Party: Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
ClinicalTrials.gov Identifier: NCT01079299     History of Changes
Other Study ID Numbers: CL-VU-0308
Study First Received: March 2, 2010
Results First Received: August 18, 2011
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Calvary Hospital, Bronx, NY:
venous ulcer
secondary lymphedema
chronic lower leg ulceration

Additional relevant MeSH terms:
Lymphedema
Ulcer
Varicose Ulcer
Venous Insufficiency
Lymphatic Diseases
Pathologic Processes
 Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013