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Status:

TERMINATED

Flexitouch Treatment for Venous Ulcers

Lead Sponsor:

Tactile Systems Technology, Inc.

Conditions:

Venous Ulcer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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® syste...

Detailed Description

A pilot randomized trial of Flexitouch® as an adjunctive treatment for venous ulcers Objectives To determine if the Flexitouch® compression therapy system, when added to standard venous ulcer (VU) tr...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT00847002

Start Date

September 1 2007

End Date

August 1 2010

Last Update

February 12 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

VA Medical Center

Minneapolis, Minnesota, United States, 55417

2

Wound Healing and Hyperbaric Center

College Station, Texas, United States, 77845