Venous Leg Ulcer Clinical Trial
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.
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Tactile Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance and comfort for subjects using a dual action pneumatic compression device | Questionnaire | 4 week | No |
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