Flexitouch Treatment for Venous Ulcers

Stopped early · Not applicable

Conditions studied: Venous Ulcer

In brief

This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers. We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in 1. greater complete healing 2. greater percentage reduction in ulcer area 3. reduced time to complete healing, as compared to the use of standard treatment alone 4. a greater reduction in affected leg volume as compared to standard treatment alone.

Key facts

Study ID

NCT00847002

Run by

Tactile Systems Technology, Inc.

People needed

8

Starts

2007-09-01

Expected to finish

2010-08-01

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be at least 18 years old
• The ulcer maximum length x its maximum width must be greater or equal to 0 cm2
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
• The ulcer must have been present for more than 1 month.
• The ulcer must be located below the knee.
• The ulcer bed must have some viable tissues with some 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 suppressive therapy
• History of collagen vascular disease
• Known malnutrition (albumin<3.0 g/dL). If malnutrition is suspected, the albumin level should be checked to determine if the patient meets the albumin criterion.
• The ulcer is clinically infected. However, patients may be entered into the study after successful treatment of infection.
• Known uncontrolled diabetes (HgbA1c > 8%). If uncontrolled diabetes is suspected, 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 mm Hg, or Toe-brachial index < 0.4). If peripheral vascular disease is suspected, vascular lab testing 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
• Chronic renal disease, if deemed by the principal investigator to be severe enough to interfere with wound healing
• Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy
• History or pulmonary embolism
• Poorly controlled asthma
• Pulmonary Edema

Where it is running

• VA Medical Center — Minneapolis, Minnesota, United States
• Wound Healing and Hyperbaric Center — College Station, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.