Clinical Trial: Flexitouch Compression System for Venous Stasis Ulcer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer

Brief Summary:

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.

Detailed Summary:

Background:

Overview of venous stasis ulcers (1-3): Venous stasis ulceration is a common complication of venous insufficiency in the United States. Venous stasis ulcers (VSU) are associated with very significant morbidity, including patient disability, moderate to severe pain, and frequent leg infections. There is also a large cost associated with the medical care needed for this condition and the inability of patients to work. In some patients, this condition can be life- or limb-threatening.

Current standard of care for VSU: It is widely accepted that VSU should be treated by an individualized program of compression wrapping therapy (3-5). This therapy is designed to counteract the presumed pathophysiology of VSU, which develop as a result of valvular reflux and venous hypertension. However, the efficacy of compression therapy alone is suboptimal, with healing rates of roughly 34% reported after 12 weeks of therapy (6). Various adjunctive treatments have been studied, including artificial skin grafts (6-8). However, none of these adjunctive modalities have become widely accepted for the treatment of VSU.

Potential role of compression pumps: Intermittent sequential compression pumps are widely used as an adjunctive modality in the treatment of VSU. These pumps use high compression and are expensive, but this expense may be outweighed by improved healing of VSU. The use of compression pumps is consistent with the pathophysiology of VSU, but data regarding the efficacy of such therapy is scarce. To date, no study has adequately assessed the efficacy of compression pump therapy in the treatment of VSU (9).

Flexitouch System: The Flexitouch System was designed by a therapist trained in manual lymphatic drainage therapy and is p
Sponsor: West Penn Allegheny Health System

Current Primary Outcome: Complete Healing Rate of Venous Stasis Ulcers [ Time Frame: 12 weeks ]

Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.


Original Primary Outcome: Complete Healing Rate of Venous Stasis Ulcers [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Change in Wound Surface Area for Non Healed Subject at 12 Weeks. [ Time Frame: 12 weeks ]
    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 ]
  • Time to Healing of the Venous Stasis Ulcer [ Time Frame: Baseline to 12 weeks ]
    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).


Original Secondary Outcome:

  • Reduction in wound surface area [ Time Frame: 12 weeks ]
  • Percentage reduction in volume of the affected limb [ Time Frame: 12 weeks ]
  • Time to Healing of the Venous Stasis Ulcer [ Time Frame: 12 weeks ]


Information By: West Penn Allegheny Health System

Dates:
Date Received: September 24, 2007
Date Started: September 2007
Date Completion:
Last Updated: January 28, 2013
Last Verified: January 2013