Flexitouch Compression System for Venous Stasis Ulcer

This study has been terminated.
(Ineffective Recruitment (Business Decision))
Sponsor:
Collaborators:
The Cleveland Clinic
Tactile Systems Technology, Inc.
Information provided by (Responsible Party):
Satish Muluk, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00534937
First received: September 24, 2007
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention Phase
Venous Stasis Ulcer
Procedure: Compression wrapping
Procedure: Flexitouch compression pump
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 Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer

Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Complete Healing Rate of Venous Stasis Ulcers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.


Secondary Outcome Measures:
  • Change in Wound Surface Area for Non Healed Subject at 12 Weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.

  • Percentage Change in Volume of the Affected Limb (-Reduction; +Increase) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to Healing of the Venous Stasis Ulcer [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).


Enrollment: 89
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard compression
Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
Procedure: Compression wrapping
Short-stretch compression wrap will be applied at least once a week.
Other Name: 3M short-stretch compression wrap
Experimental: Flexitouch
Patients in this arm will receive once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Procedure: Flexitouch compression pump
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.
Other Names:
  • Flexitouch compression pump
  • 3M compression wrap

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00534937

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Allegheny General Hospital Advanced Wound Healing and Lymphedema Center
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
The Cleveland Clinic
Tactile Systems Technology, Inc.
Investigators
Principal Investigator: Satish Muluk, MD West Penn Allegheny Health System
  More Information

Publications:

Responsible Party: Satish Muluk, Professor, Surgery, Temple University School of Medicine; Associate Professor, Cardiothoracic Surgery, Drexel University College of Medicine, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00534937     History of Changes
Other Study ID Numbers: RC-4372
Study First Received: September 24, 2007
Results First Received: November 29, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Venous stasis ulcer
Compression pump
Randomized trial
Flexitouch compression

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014