Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

Study Overview
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Brief Summary
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The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.

Detailed Description
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Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.

Official Title
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Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: Dual Action Pneumatic Compression Device
* Device: Standard Compression Garments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of unilateral or bilateral CVI with or without leg ulcers Documented history of low adherence to compression garment therapy CEAP classification C3-C6 Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm Exclusion Criteria: History of skin sensitivity to any of the components of ACTitouch or compression garments History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months Ankle Brachial Index (ABI) < 0.8 Acute thrombophlebitis History of pulmonary edema or decompensated congestive heart failure Currently has an active infection of the skin such as cellulitis requiring antibiotics Poorly controlled diabetes with an HbA1c value of >10% Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable. Subjects with open ulcers must be able to follow their care regimen for ulcer healing concurrently with the assigned study regimen. Participating in another clinical trial Changes to medications that affect edema within the last 30 days Currently pregnant or trying to become pregnant

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTitouch<br>ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day. | Device: Dual Action Pneumatic Compression Device<br>* A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.<br>|
| Active Comparator: Standard Compression Garments<br>Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day. | Device: Standard Compression Garments<br>* Compression stockings with a 30-40mmHg level of compression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use and Comfort for Subjects Using the ACTitouch System. | Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic venous insufficiency, venous leg ulcers, pneumatic compression