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OpenTrials
Completed

NCT Number: NCT02015221

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

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.

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Key information

Conditions

Chronic Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Associated Foot and Ankle Specialists, LLC, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual Action Pneumatic Compression Device

Device

A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.

Standard Compression Garments

Device

Compression stockings with a 30-40mmHg level of compression.

Primary outcomes

  1. Ease of Use and Comfort for Subjects Using the ACTitouch System.

    Time frame: 30 days

    Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.

Sponsors and collaborators

Lead sponsor

Tactile Medical

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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