Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing (UltraHeal)

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

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.

Study Overview

• Status: Completed
• Conditions: WOUNDS
• Intervention / Treatment: Device: Ultrasound debridement; Device: Best practice wound care

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital Wound Healing Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasound debridement; Participants receiving ultrasound assisted debridement in addition to best practice wound care.	Device: Ultrasound debridement; 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.; Other Names: Misonix Sonic One Ultrasound Wound Care System
ACTIVE_COMPARATOR: Best Practice wound care; Participants receiving best practice wound care alone	Device: Best practice wound care; Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Christine A. Murphy, MClSc PhD(c), The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (ESTIMATE): October 31, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes; Wound infection; Wounds; Debridement; Arterial Insufficiency; Lower extremity; Wound bed preparation; Low frequency ultrasound; Contact ultrasound; Wound clinic; Chronic wound inflammation
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20130152-01H