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Completed

NCT Number: NCT02395302

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

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.

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Chronic Venous Insufficiency Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Insufficiency Venous Stasis Ulcer Venous Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Research, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dual Action Pneumatic Compression

Device

Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.

Other names: ACTitouch system

Primary outcomes

  1. Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Tactile Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2015
Registry last updated
Mar 27, 2017

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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