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

Study Overview
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Brief Summary
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Wound healing rate is higher when contact ultrasound therapy is followed by noncontact ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.

Detailed Description
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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 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

Official Title
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Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy: The VIP Ultrasound Protocol

Conditions
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Chronic Ulcer of Lower Extremity

Intervention / Treatment
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* Device: Contact Ultrasound Therapy
* Device: Noncontact Ultrasound Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory Wound Clinic<br>Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic. | Device: Contact Ultrasound Therapy<br>* Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.<br>* Other names: Soring, Sonoca-180;Device: Noncontact Ultrasound Therapy<br>* Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.<br>* Other names: Celleration Inc, MIST Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Wound Area | Mean and Standard Deviation of the group's total wound area at day one and last treatment day. Wound area was measured as Length x Width. This is to assess the change in area, in order to assess wound progress towards closure. | Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Wound Volume | Mean and Standard Deviation of the group's total wound volume at day one and last treatment day. Wound volume was measured as Length x Width X Depth (when able to determine depth). This is to assess the change in volume, in order to assess wound progress towards closure. | Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | 
| Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Mean and Standard Deviation of the group's percent adherent and/or non-adherent slough present in the wound bed at day one and last treatment day. This is to assess the change in slough/eschar. This is to determine progression from contact to noncontact ultrasound therapy, as well as to determine progress of wound bed quality. | Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Sub-acute wound, Chronic wound, MIST, Soring, Contact Ultrasound, Noncontact ultrasound, Wound Care, VIP Ultrasound Protocol, Wound