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

Venous Leg Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395302
• Other study ID #: 6020
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: October 21, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 an 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Leg Ulcer
• Venous Stasis Ulcer
• Venous Ulcer

Intervention

Device:
• Dual Action Pneumatic Compression
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	University of Miami School Hospital	Miami	Florida
United States	St. Luke's Roosevelt Hospital Center	New York City	New York
United States	Center for Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance and comfort for subjects using a dual action pneumatic compression device	Questionnaire	4 week	No