Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2015

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.

Interventions

  • 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.
  • Device: Best practice wound care
    • Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.

Arms, Groups and Cohorts

  • Experimental: Ultrasound debridement
    • Participants receiving ultrasound assisted debridement in addition to best practice wound care.
  • Active Comparator: Best Practice wound care
    • Participants receiving best practice wound care alone

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Protease activity
    • Time Frame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
    • 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.
  • Bacterial burden
    • Time Frame: Pre-treatment, week 5 and week 12
    • 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
  • Number of wounds healed
    • Time Frame: Throughout duration of the study
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine A. Murphy, MClSc PhD(c), Principal Investigator, The Ottawa Hospital

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