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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Venous Leg Ulcer Chronic Venous Insufficiency Venous Stasis Ulcer Venous Ulcer Venous Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dual Action Pneumatic Compression

Intervention Type DEVICE

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

Interventions

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Dual Action Pneumatic Compression

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

Intervention Type DEVICE

Other Intervention Names

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ACTitouch system

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No