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

Study Overview
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Brief Summary
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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).

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

Conditions
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Lymphedema

Intervention / Treatment
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* Device: Intermittent, gradient, pneumatic compression device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPC plus standard compression<br> | Device: Intermittent, gradient, pneumatic compression device<br>* lymphedema pump provides external compression in a segmental,gradient fashion<br>* Other names: Bio 4000 (Bio Compression Inc, Moonachie,NJ);|
| Active Comparator: Standard compression alone<br> | Device: Intermittent, gradient, pneumatic compression device<br>* lymphedema pump provides external compression in a segmental,gradient fashion<br>* Other names: Bio 4000 (Bio Compression Inc, Moonachie,NJ);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous ulcer, secondary lymphedema, chronic lower leg ulceration