Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

Study Overview
=================
Brief Summary
-----------------
The UltraHeal Study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of the lower extremity.

Detailed Description
-----------------
The study will also investigate the bacterial tissue burden and protease activity to provide further insight into the infection and inflammation aspects of healing barriers in a challenging population.

Official Title
-----------------
A Randomized Controlled Trial to Investigate if Application of Low Frequency Ultrasound-assisted Debridement May Improve Healing and Infection Outcomes for the Person With Vasculopathy and Recalcitrant Wounds of the Lower Extremity

Conditions
-----------------
WOUNDS

Intervention / Treatment
-----------------
* Device: Ultrasound debridement
* Device: Best practice wound care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with lower extremity wound referred to vascular surgery service. Full thickness wound below the knee with surface area of at least 1cm2. Age >18 years English speaking Ulcer of known etiology including diabetic foot wounds, and arterial or venous leg ulcers Willing and able to adhere to 12 week study protocol that includes attending weekly clinic appointments, and wearing prescribed footwear or compression therapy Exclusion Criteria: Leg wounds due to inflammatory conditions (e.g. pyoderma gangrenosum, vasculitis), malignancy, or other unknown etiologies. Severe arterial insufficiency: Absence of pedal pulses combined with Ankle Brachial Index ≤ 0.3, Toe Pressure ≤20, or Trans Cutaneous Oxygen Measure ≤20 Presence of acute limb threatening infection Vascular surgery planned within next 3 months Exposed vascular graft or blood vessel, bone or tendon in the base of the wound. Currently receiving advanced wound therapy treatments: Hyperbaric therapy, biological dressings [collagen or extracellular matrix dressings]. Increased likelihood of an adverse reaction to ultrasonic debridement due to: Excessive wound pain (>5 VAS scale) or patient described intolerable Allergy to topical anesthetic (lidocaine) Individuals who have factors/circumstances that are known to limit their ability to demonstrate healing in 4 weeks. For example: medically unstable or palliative medical status poor nutritional status (low serum albumin < 15), anemia (Hb < 75 mg/dl), taking immunosuppressant medication (prednisone, chemotherapy; transplant anti-rejection medication), Individuals with medical conditions that contraindicate the use of ultrasound energy Cardiac pacemaker or defibrillator Excessive bleeding tendency (> 5 mins post debridement) or identified coagulopathic disorders Exposed bone in the wound base Untreated osteomyelitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound debridement<br>Participants receiving ultrasound assisted debridement in addition to best practice wound care. | Device: Ultrasound debridement<br>* Ultrasound-assisted wound debridement with saline irrigant applied for 5 - 15 minutes until visible and removable non-viable appearance tissue is removed to reveal a healthy appearance wound bed.<br>* Other names: Misonix Sonic One Ultrasound Wound Care System;|
| Active Comparator: Best Practice wound care<br>Participants receiving best practice wound care alone | Device: Best practice wound care<br>* Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound surface area | The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy. | Weekly for 4 weeks then at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protease activity | A wound swab to test for elevated protease activity will be obtained before treatment and at week5 (after the 4 weekly treatments), and then again at week 12 to ascertain the immediate and sustained impact on inflammatory aspects of wound healing. | Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks. | 
| Bacterial burden | A tissue culture to test for elevated bacterial activity and species identification will be obtained before treatment and at week 5 (after the 4 weekly treatments), and then again at week 12 to ascertain the immediate and sustained impact on infection aspects of wound healing | Pre-treatment, week 5 and week 12 | 
| Number of wounds healed | We will count the number of wounds that have healed and have not healed for each group and compare to ascertain if the therapy improves healing. | Throughout duration of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wounds, Lower extremity, Diabetes, Arterial Insufficiency, Debridement, Low frequency ultrasound, Contact ultrasound, Wound clinic, Wound bed preparation, Wound infection, Chronic wound inflammation