Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
Completed · Not applicable
Conditions studied: Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
In brief
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.
Key facts
- Study ID
- NCT02395302
- Run by
- Tactile Medical
- People needed
- 28
- Starts
- 2014-12-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2017-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- Currently participating in another clinical trial.
Where it is running
- Center for Clinical Research — San Francisco, California, United States
- University of Miami School Hospital — Miami, Florida, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Englewood Hospital and Medical Center — Englewood, New Jersey, United States
- St. Luke's Roosevelt Hospital Center — New York, New York, United States
Full record on ClinicalTrials.gov
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