Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol

This prospective pilot study is designed to evaluate the clinical effectiveness of a wound
care ultrasound treatment protocol for sub-acute or chronic wounds of the lower extremity and
of any etiology. The Viana-Pompeo (VIP) ultrasound protocol consists of high intensity, low
frequency, contact ultrasound therapy (with Sonoca-180) followed by low intensity,
low-frequency, noncontact ultrasound therapy (with MIST Therapy). Previously published
healing rates for each of the ultrasonic therapy modalities will be used as a comparison.

The Physical Therapist will perform the initial assessment and treatment, and devise an
individualized plan of care that involves contact ultrasound followed by noncontact
ultrasound. Subjects may remain in the study for up to 12 weeks, or up to when end of study
criteria is met.

Transition from contact mode to noncontact mode will happen when:

- Wound is sufficiently clean with ≤ 20% of necrotic tissue or adherent slough.

OR

- >= 80% of soft slough is easily removed from the wound bed with mechanical or selective
debridement before or after treatment

OR

- Wound bed quality has failed to progress after 3 consecutive contact ultrasound treatments

For the purposes of this study, treatments will be performed 3 times a week. Treatment time
will be dependent on the wound area, at least 20 sec/cm2, per standard protocol.

Only the wounds present during Physical Therapy (PT) initial assessment will be included in
the research. If the patient develops new wounds during the course of the research, the
patient will receive appropriate treatment, but such wounds will not be part of the study.

Patients in the wound clinic setting are allowed to perform home dressing changes as ordered
by the physician in addition to the dressing changes performed by the therapist or wound
clinic nurse on clinic visit days. Patients and/or caregivers will be trained in dressing
changes techniques and must understand the procedure prior to performing dressing changes on
their own.

In addition to ultrasonic treatment and dressing changes, wound debridement may be performed
each visit as needed. Digital photography and wound measurements will also be performed
weekly and as needed.

End of PT wound therapy may be before, at, or after the end of the study period. The
beginning of the MIST therapy will depend on the individual characteristics and wound needs.

A minimum of 4 MIST treatments must be completed for a patient's data to be included the data
analysis in the acute care setting.

A minimum of 2 treatments per week (goal of 3 per week) must be reached for the 12 week
period for a patient's data to be included in the data analysis.

Study Endpoints

Primary endpoint:

- Wound area reduction

- Percent granulation tissue

- Length of the study for ambulatory subjects: 12 weeks from Start of Contact Ultrasound
therapy

- Length of the study for acute care subjects: From Start of Contact Ultrasound therapy up
to 12 weeks or until patient is discharged from the hospital.

Secondary endpoint:

- Wound closure at any point within the length of study

- Failure to note improvement in wound area, and/or wound volume, and/or wound bed quality
after 4 consecutive weeks of treatment.

- 3 consecutive missed visits, or a total of 7 missed visits

Inclusion Criteria:

- Patient is referred to Physical Therapy for contact ultrasound (which is included in
the VIP protocol);

- Lower extremity (including foot) wound(s) of any etiology;

- Wound(s) presenting with slough, necrotic tissue, and/or non-viable tissue requiring
debridement;

- Wound is present for 4 weeks or longer at the start of ultrasonic therapy;

- Insurance approval is obtained for Contact and Noncontact ultrasound treatments, in
the ambulatory setting;

- Patient is 18 years of age or older;

- Female patient attesting not to be pregnant;

- Not undergoing Vacuum Assisted Closure (VAC) therapy.

Exclusion Criteria:

- Patient is referred to Physical Therapy for noncontact ultrasound only;

- Wound(s) not on lower extremity;

- Clean wound(s) that do not require debridement;

- Wound onset less than 4 weeks prior to the start of ultrasonic therapy;

- Malignancies on the treatment area;

- Patients in the ambulatory setting whose insurance did not approve them for both
contact and noncontact ultrasound therapy;

- Patient is under 18 years of age;

- Female patient attesting to be pregnant;

- VAC Therapy.