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

NCT02395302 | Completed Results

• 1 other identifier: 6020
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode. 2. The device was comfortable to wear during Intermittent Compression Mode. 3. The noise from the device was not bothersome. 4. The device was easy to put on. 5. The device was easy to take off. 6. The device was easy to use. 7. The device was light-weight and portable. 8. The use of the device helped my wound heal faster. 9. I would use the device again on another wound in the future. 10. Since using the device, my quality of sleep has improved. 11. It was a burden to come to the wound care clinic for my dressing changes. 12. The use of the device did not restrict many of my normal activities. 13. The device was cumbersome and interfered with my mobility. 14. I was able to work while being treated with the device.

  4 weeks

Study Arms (1)

Dual Action Pneumatic Compression

EXPERIMENTAL

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

Device: Dual Action Pneumatic Compression

Interventions

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.

Also known as: ACTitouch system

Dual Action Pneumatic Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (6)

Center for Clinical Research

San Francisco, California, 94115, United States

Location

University of Miami School Hospital

Miami, Florida, 33125, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Tactile Medical

mbroich@tactilemedical.com

(612)355-5123

Study Officials

• William Marston, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 23, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 27, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)