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

Tactile Medical

Status: Completed

Conditions: Venous Leg Ulcer; Venous Ulcer; Venous Insufficiency; Venous Stasis Ulcer; Chronic Venous Insufficiency

Treatments: Device: Dual Action Pneumatic Compression

Study type: Interventional

Funder types: Industry

Identifiers

NCT02395302

6020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Dual Action Pneumatic Compression

Experimental group

Description:

Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet.

Treatment:

Device: Dual Action Pneumatic Compression