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

Not Applicable

Completed

• Conditions: Venous Ulcer; Venous Leg Ulcer; Chronic Venous Insufficiency; Venous Insufficiency; Venous Stasis Ulcer
• Interventions: Device: Dual Action Pneumatic Compression

• Registration Number: NCT02395302
• Lead Sponsor: Tactile Medical

Brief Summary

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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-23
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Results First Submitted: 2017-01-03
• Results First Submitted QC: 2017-01-03
• Status Verified: 2017-02
• Results First Posted: 2017-02-23
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dual Action Pneumatic Compression	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device	4 weeks	A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode.; 2. The device was comfortable to wear during Intermittent Compression Mode.; 3. The noise from the device was not bothersome.; 4. The device was easy to put on.; 5. The device was easy to take off.; 6. The device was easy to use.; 7. The device was light-weight and portable.; 8. The use of the device helped my wound heal faster.; 9. I would use the device again on another wound in the future.; 10. Since using the device, my quality of sleep has improved.; 11. It was a burden to come to the wound care clinic for my dressing changes.; 12. The use of the device did not restrict many of my normal activities.; 13. The device was cumbersome and interfered with my mobility.; 14. I was able to work while being treated with the device.

Trial Locations

Locations (6)

Center for Clinical Research; 🇺🇸 San Francisco, California, United States

University of Miami School Hospital; 🇺🇸 Miami, Florida, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York City, New York, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States