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

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: Intermittent, gradient, pneumatic compression device

• Registration Number: NCT01079299
• Lead Sponsor: Calvary Hospital, Bronx, NY

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-08
• Results First Submitted: 2011-08-18
• Results First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Results First Posted: 2012-02-10
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard compression alone	Intermittent, gradient, pneumatic compression device	-
IPC plus standard compression	Intermittent, gradient, pneumatic compression device	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Calvary Hospital, Center for Curative and Palliative Wound Care; 🇺🇸 Bronx, New York, United States