Flexitouch Treatment for Venous Ulcers

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) treatment, results in: 1. Greater complete healing at 12 weeks as
compared to standard treatment alone. 2. Greater percentage reduction in ulcer area at 12
weeks as compared to standard treatment alone. 3. Less time to complete healing as compared
to standard treatment alone 4. A greater reduction in the leg volume of the affected leg

Hypothesis 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, and 4) a greater
reduction in affected leg volume as compared to standard treatment alone.

Patient recruitment, eligibility, and exclusions Patients who present at our clinic with a
venous leg ulcer, as judged by clinical presentation and history, will be recruited for
participation in this research study. For this pilot study a total of 16 patients will be
recruited.

Protocol and Procedures After verifying eligibility and administering an approved informed
consent, patients will be randomized to one of the study arms (A or B). Study patients will
be seen one or two times per week (per physician's discretion) for 12-weeks for standard
wound care and treatment. For both groups, sustained compression will be achieved with the
FarrowWrapâ„¢ Classic device. This device will be worn continuously except during the
twice-weekly treatments and when Flexitouch therapy is being undertaken (Group B only).
Group B will use Flexitouch at home every day (twice daily); Group A will not use
Flexitouch. Once per week, treatment and parameter assessments will be undertaken as
described below.

Standard Wound Care and Treatment 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. For venous ulcer
treatment it is applied at full stretch. The patient will be given instructions as to how to
apply the FarrowWrap at home.

Flexitouch System and its Use Patients who have been randomized to Group B 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. The system consists of a controller
unit with four eight-port connectors and a garment set for the trunk and leg. The garments
are placed around the trunk and affected limbs and are connected to the controller by a
tubing harness. The controller inflates and deflates the air chambers within the garments in
a pre-determined pattern to assist the lymphatics in moving the fluid into adjacent lymph
node regions of the trunk. The controller inflates individual chambers in the garments for
1-3 seconds per inflation.

Potential Treatment modifications The patient's welfare, as determined by the principal
investigator, will take precedence over any study procedures. Any interventions necessary
for the patient's welfare will be undertaken as necessary.

Wound Photography The wound will be photographed using a digital camera with zoom capability
supplied by the sponsor of this study. All photographs will be taken with the camera
pointing directly down to the wound such that the angle between the camera and the
plane-of-the wound is as near to 90o as possible. Flash will be avoided if there is adequate
lighting. The vertical distance from the wound to the camera is not critical but a distance
of about 20 cm will be used when possible. Prior to taking photographs, a suitable
dimensional scale or calibration standard will be placed in contact with the skin near, but
outside a wound margin. In the case of a one-dimensional scale, it will be placed above or
below the wound, and positioned along the long dimension of the wound. A suitable
calibration standard will be supplied by the sponsor of this study. The framing of the photo
will be such as to include 1) the complete wound bed, 2) a small sampling of the surrounding
periwound tissue and 3) the calibration standard or scale. The composed image, as viewed
through the camera LCD viewport, will be as large as possible while still including the
required elements. The camera will be oriented such that the horizontal dimension of the LCD
viewport is parallel to the horizontal calibration scale on the leg.

Wound Tracing After photographing, the wound margins will be traced by placing a transparent
grid over the wound. The grid is a commercial product (E-Z Graph) that is designed for this
purpose. It consists of two layers; a bottom layer which is in contact with the wound and an
upper layer on which tracing is done using a colored pen. The upper layer has a grid system
with 1 x 1 cm squares imbedded into the material. After tracing the bottom layer is
discarded. The patient's study ID, visit number and visit date are then recorded on a space
provided on the upper tracing grid.

Assessment of Leg Volumes Leg volumes of both right and left legs from ankle to knee will be
determined. This is done using a calibrated tape measure (Gulick-type) to measure
circumferences at 4 cm intervals starting at the malleoulus and progressing toward the knee.
From these circumference measurements, limb volumes will be determined using the well
established truncated cone model together with a validated software algorithm. Using this
method the wound assessor enters the circumferences into a standardized form and the
appropriate volumes are automatically determined.

Assessment of Complete Wound Healing At each visit the wound will be carefully inspected by
the Principal Investigator and the presence or absence of complete wound healing noted and
recorded. For this study, wound healing will be considered to occur when the wound is fully
covered with epithelium and there is no drainage. In addition, at each visit, a
study-related case report form will be completed by the Principal Investigator to document
various clinical features of the wound and to note any relevant study-related actions or
events. This form will be embedded within password protected software so that most wound
descriptors will be able to be entered and documented with a simple mouse click.

Analysis of Wound Areas and Related Parameters Wound Areas by Photo Images: The digital
images of the wound will be coded by the Principal Investigator by suitably renaming each
photographic image file with a unique identifier. He will keep a record of these coded file
names and the group, patient, and visit date and number to which they correspond. A copy of
each image file will be made and stored on a CD. The CD will be sent to a scientific advisor
who works with the study sponsor. The advisor will be responsible for the analyses of the
images, including the determination of wound areas via computerized planimetry and for
subsequent data and statistical analyses. The analyst will blind as to which actual group
the images correspond. At the completion of the data acquisition phase of the study, the
analyst will be told which images belong to common groups, but he will still not know which
of the common groups belong to which arm of the study. He will thus remain blind during the
subsequent statistical analyses.

Wound Areas by Tracings: As a complementary comparison approach, wound areas will also be
assessed from the wound tracings. The analyst will be supplied with copies of the coded
tracings. The tracings will then be scanned and the wound areas determined by computerized
digital planimetry as previously described. Areas determined by this method will serve as a
check measurement and will be used as a backup in those cases (if any) in which photographic
quality is inadequate.

Leg Volumes: In addition to photographs and tracings, the analyst will be supplied with
coded electronic copies of the leg circumference forms. This data will be used to determine
if, and to what extent, changes in leg volume or edema occur, and if there are differences
in these parameters between groups A and B.

Wound Descriptors: A coded electronic version of the case report form, containing wound
descriptor parameters data, will be supplied to the analyst. This information will be used
primarily in the final analysis to summarize the clinical progression of the wounds.