Flexitouch Compression System for Venous Stasis Ulcer

Stopped early · Phase 4

Conditions studied: Venous Stasis Ulcer

In brief

The researchers hypothesize that utilization of the Flexitouch system will improve the healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping therapy alone. Primary Objective: The primary study objective is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping. Secondary Objectives: * To determine whether the addition of Flexitouch System compression therapy to a standard regimen of compression wrapping increases the percentage reduction in wound surface area. * To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping increases the percentage reduction in volume of the affected limb. * To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping decreases the time to healing of the venous stasis ulcer.

Key facts

Study ID

NCT00534937

Run by

West Penn Allegheny Health System

People needed

89

Starts

2007-09-01

Expected to finish

2010-12-01

Last updated by the study team

2013-03-01

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both.
• Patients must be 18 years old or more.
• The VSU size must be in the range 1-64 cm2.
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
• The VSU must have been present for more than 1 month.
• The ulcer must be located between and including the knee and ankle.
• The wound bed must have viable tissues with granulation tissue.

You may not qualify if…

• Exposed bone, tendon, or fascia.
• Severe rheumatoid arthritis.
• History of radiotherapy to the ulcer site.
• Uncontrolled congestive heart failure.
• Receiving corticosteroids or immune suppressives.
• History of collagen vascular disease.
• Known malnutrition (albumin < 2.5 g/dL). If malnutrition is suspected by the principal investigator, the albumin level should be checked to determine whether the patient meets the albumin criterion.
• Ulcer clinically infected at the time of entry into the study. However, patients may be entered into the study after successful treatment of infection.
• Known uncontrolled diabetes (HgbA1c > 12%). If the principal investigator suspects uncontrolled diabetes, the Hgb A1c should be checked to determine patient eligibility.
• Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
• Known arterial insufficiency (Ankle-brachial index < 0.7, or TCPO2 < 35 mmHg, or Toe brachial index < 0.4). If the principal investigator suspects uncontrolled diabetes, the Ankle-brachial index should be checked to determine patient eligibility.
• Active sickle cell disease.
• Unable to comply with the procedures described in the protocol.
• Enrolled in a clinical evaluation for another investigational wound-care device or drug.
• Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months.
• Pregnancy, suspected or confirmed.
• History of peripheral vascular disease, or chronic renal disease.
• Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy.
• History of pulmonary embolism.
• Poorly controlled asthma.
• Use of Apligraf, skin graft or similar biological dressing within 30 days of study entry.
• Patients with concurrent atrophie blanche.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States
• Allegheny General Hospital Advanced Wound Healing and Lymphedema Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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