Flexitouch Compression System for Venous Stasis Ulcer
Condition: Venous Stasis Ulcer
MeSH terms: Varicose Ulcer; Ulcer
Intervention: Compression wrapping; Flexitouch compression pump
Intervention description: Short-stretch compression wrap will be applied at least once a week.; In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Venous stasis ulcer; Compression pump; Randomized trial; Flexitouch compression

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.