Flexitouch Treatment for Venous Ulcers

This study has been terminated.
(Lack of Enrollment)
Sponsor:
Information provided by (Responsible Party):
Tactile Medical ( Tactile Systems Technology, Inc. )
ClinicalTrials.gov Identifier:
NCT00847002
First received: February 18, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.

Condition Intervention Phase
Venous Ulcer
Device: Standard Wound Care
Device: Flexitouch System with Standard Wound Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Randomized Trial of Flexitouch as an Adjunctive Treatment for Venous Ulcers

Further study details as provided by Tactile Medical:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in Leg Volume [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard Wound Care
Device: Standard Wound Care
Standard wound care treatment will include gentle wound ulcer cleansing with saline solution at each visit, maintaining moisture balance in the wound and periwound with appropriate dressings (e.g Acticoat, Aquacel Ag, or Mepilex Ag foam dressings), reminding subjects of the importance of proper nutrition, leg elevation at rest and activity, including frequent ambulation and ankle range of motion exercises through the day. The FarrowWrap Classic device is applied over the dressing to achieve suitable compression pressures as an important component of the standard treatment.
Other Name: Farrow Wrap
Active Comparator: 2
Flexitouch system with Standard Wound Care
Device: Flexitouch System with Standard Wound Care
In addition to standard wound care, patients who have been randomized to this group will be provided a home Flexitouch unit. They will be given instructions to use it on a twice daily basis. They will be instructed to remove the FarrowWrap during the time they are using Flexitouch. The Flexitouch System works by applying dynamic low-pressure compression to the trunk and affected limbs using gentle, rhythmic massage action.
Other Name: Flexitouch system

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be at least 18 years old
  2. The ulcer maximum length x its maximum width must be greater or equal to 0 cm2
  3. The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
  4. The ulcer must have been present for more than 1 month.
  5. The ulcer must be located below the knee.
  6. The ulcer bed must have some viable tissues with some granulation tissue.

Exclusion Criteria:

  1. Exposed bone, tendon, or fascia
  2. Severe rheumatoid arthritis
  3. History of radiotherapy to the ulcer site
  4. Uncontrolled congestive heart failure
  5. Receiving corticosteroids or immune suppressive therapy
  6. History of collagen vascular disease
  7. 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.
  8. The ulcer is clinically infected. However, patients may be entered into the study after successful treatment of infection.
  9. Known uncontrolled diabetes (HgbA1c > 8%). If uncontrolled diabetes is suspected, the Hgb A1c should be checked to determine patient eligibility.
  10. Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
  11. 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.
  12. Active sickle cell disease
  13. Unable to comply with the procedures described in the protocol
  14. Enrolled in a clinical evaluation for another investigational wound-care device or drug
  15. Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months
  16. Pregnancy, suspected or confirmed
  17. Chronic renal disease, if deemed by the principal investigator to be severe enough to interfere with wound healing
  18. Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy
  19. History or pulmonary embolism
  20. Poorly controlled asthma
  21. Pulmonary Edema
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847002

Locations
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Texas
Wound Healing and Hyperbaric Center
College Station, Texas, United States, 77845
Sponsors and Collaborators
Tactile Systems Technology, Inc.
Investigators
Principal Investigator: Wade Farrow, MD Wound Healing and Hyperbaric Center
Study Director: Sunday Hoy, JD Tactile Systems Techonology Inc.
  More Information

No publications provided

Responsible Party: Tactile Medical ( Tactile Systems Technology, Inc. )
ClinicalTrials.gov Identifier: NCT00847002     History of Changes
Other Study ID Numbers: FWFT07312007
Study First Received: February 18, 2009
Results First Received: May 31, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tactile Medical:
Flexitouch system
FarrowWrap
venous stasis ulcer

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014