Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort in Patients With Venous Leg Ulcers

The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency; Venous Leg Ulcer; Chronic Venous Insufficiency; Venous Ulcer; Venous Stasis Ulcer
• Intervention / Treatment: Device: Dual Action Pneumatic Compression

Detailed Description

Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami School Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
  • New York
    • New York City, New York, United States, 10025
      • St. Luke's Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be ≥ 18 years of age or legal age at the time of enrollment.
• Chronic venous insufficiency confirmed by ultrasound within previous 12 months.
• Active ulceration (CEAP classification of C6)
• Ulcer duration: ≥ 2 month but not greater than 24 months - non healing VLU with conservative treatment.
• Ulcer size ≥ 2cm2 ≤ 50cm2
• Leg circumferences within the following range:Ankle - 12 to 44cm;Calf - 22 to 60cm; Below knee - 22 to 68cm

Exclusion Criteria:

• Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
• Greater than 3 separate full thickness ulcers on the study limb
• Target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
• Treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment.
• History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 3 months.
• Either the dorsalis pedis (DP) or posterior tibial (PT) systolic pressure < 80mmHg for diabetic patients or < 60mmHg for non-diabetic patients on study limb or transcutaneous partial pressure oxygen (Tcp02) ≤ 30mmHg or great toe systolic pressure ≤ 40mmHg.
• Acute thrombophlebitis.
• History of pulmonary edema or decompensated congestive heart failure.
• Currently has an active infection of the skin such as cellulitis requiring antibiotics.
• History of cancer within the last 5 years with the exception of treated non-melanoma skin cancer or cervical carcinoma in situ.
• Poorly controlled diabetes with a Hemoglobin A1c (HbA1c) value of >12%.
• Changes to medications that affect edema within the last 30 days
• Need for current and ongoing therapy with corticosteroids (exception for continued low dose usage) or cytotoxic drugs or the current use of Daflon 500.
• Currently pregnant or trying to become pregnant.
• Inability or unwillingness to participate in all aspects of study protocol.
• Currently participating in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Action Pneumatic Compression; Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet.	Device: Dual Action Pneumatic Compression; Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.; Other Names: ACTitouch system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device	A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: The device was comfortable to wear during Sustained Compression Mode.; The device was comfortable to wear during Intermittent Compression Mode.; The noise from the device was not bothersome.; The device was easy to put on.; The device was easy to take off.; The device was easy to use.; The device was light-weight and portable.; The use of the device helped my wound heal faster.; I would use the device again on another wound in the future.; Since using the device, my quality of sleep has improved.; It was a burden to come to the wound care clinic for my dressing changes.; The use of the device did not restrict many of my normal activities.; The device was cumbersome and interfered with my mobility.; I was able to work while being treated with the device.	4 weeks

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: Principal Investigator: William Marston, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: 6020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO