Clinical trial NCT02395302: Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
Official title: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort in Patients With Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Chronic Venous Insufficiency
Venous Stasis Ulcer
Venous Ulcer
Venous Insufficiency
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2015-03-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Miami
country: United States
facility: University of Miami School Hospital
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York City
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
References: