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

Tactile Medical

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Device: Dual Action Pneumatic Compression Device; Device: Standard Compression Garments

Study type: Interventional

Funder types: Industry

Identifiers

NCT02015221

ACTitouch EOU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

ACTitouch

Experimental group

Description:

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.

Treatment:

Device: Dual Action Pneumatic Compression Device

Standard Compression Garments

Active Comparator group

Description:

Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.

Treatment:

Device: Standard Compression Garments