Flexitouch Compression System for Venous Stasis Ulcer - Full Text View

Sponsor:	West Penn Allegheny Health System
Collaborator:	The Cleveland Clinic
Information provided by:	West Penn Allegheny Health System
ClinicalTrials.gov Identifier:	NCT00534937

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 IV

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 ]

Secondary Outcome Measures:

Reduction in wound surface area [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage reduction in volume of the affected limb [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to healing of the venous stasis ulcer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
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 (twice-weekly short-stretch compression wrapping).	Procedure: Compression wrapping Short-stretch compression wrap will be applied twice a week. Other Name: 3M short-stretch compression wrap
Experimental: Flexitouch Patients in this arm will receive twice-a-week short stretch compression wrapping AND twice-daily Flexitouch pump application (including Flexitouch application twice-a-week in the clinic setting).	Procedure: Flexitouch compression pump In addition to short-stretch wrapping, this group will received twice-daily Flexitouch compression pump, both at home and during the twice-a-week clinic visits. Other Names: Flexitouch compression pump 3M compression wrap

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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

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

Investigators

Principal Investigator:

Satish Muluk, MD

West Penn Allegheny Health System

More Information

Publications:

Palfreyman SJ, Nelson EA, Lochiel R, Michaels JA. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006 Jul 19;3:CD001103. Review.

Pascarella L, Schonbein GW, Bergan JJ. Microcirculation and venous ulcers: a review. Ann Vasc Surg. 2005 Nov;19(6):921-7. Review.

Black SB. Venous stasis ulcers: a review. Ostomy Wound Manage. 1995 Sep;41(8):20-2, 24-6, 28-30 passim. Review.

Kramer SA. Compression wraps for venous ulcer healing: a review. J Vasc Nurs. 1999 Dec;17(4):89-97; quiz 98-9. Review.

Hansson C. Optimal treatment of venous (stasis) ulcers in elderly patients. Drugs Aging. 1994 Nov;5(5):323-34. Review.

Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43.

O'Donnell TF Jr, Lau J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. J Vasc Surg. 2006 Nov;44(5):1118-25. Review.

Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999 Jul-Aug;7(4):201-7.

Berliner E, Ozbilgin B, Zarin DA. A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers. J Vasc Surg. 2003 Mar;37(3):539-44. Review.

Wollina U, Abdel-Naser MB, Mani R. A review of the microcirculation in skin in patients with chronic venous insufficiency: the problem and the evidence available for therapeutic options. Int J Low Extrem Wounds. 2006 Sep;5(3):169-80. Review.

Felty CL, Rooke TW. Compression therapy for chronic venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):36-40. Review.

Responsible Party:	Satish Muluk MD, Allegheny General Hospital
ClinicalTrials.gov Identifier:	NCT00534937 History of Changes
Other Study ID Numbers:	RC-4372
Study First Received:	September 24, 2007
Last Updated:	June 14, 2011
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 February 09, 2012