Clinical trial NCT02045303: Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
Official title: Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy: The VIP Ultrasound Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ulcer of Lower Extremity
Keywords: Sub-acute wound
Chronic wound
Wound
MIST
Soring
Contact Ultrasound
Noncontact ultrasound
Wound Care
VIP Ultrasound Protocol
Ultrasound
Lead sponsor: Texas Health Resources
Sponsor class: OTHER
Collaborators: name: Celleration, Inc.
First posted: 2014-01-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Total Wound Area
timeFrame: 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 outcomes:
measure: Total Wound Volume
timeFrame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
measure: Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit
timeFrame: Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Other outcomes:
measure: Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit
timeFrame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Locations:
city: Dallas
country: United States
facility: Texas Health Resources - Presbyterian Hospital of Dallas
state: Texas
Study officials:
affiliation: Texas Health Resources - Presbyterian Hospital of Dallas
name: Lisley Viana, PTMS
role: PRINCIPAL_INVESTIGATOR
References: