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

Completed · Not applicable

Conditions studied: Lymphedema

In brief

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).

Key facts

Study ID

NCT01079299

Run by

Calvary Hospital, Bronx, NY

People needed

52

Starts

2007-12-01

Expected to finish

2010-05-01

Last updated by the study team

2012-02-10

Who can join

Age: 21 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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