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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: July 2015
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.
- 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
- 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.
- 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
- 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
- Lead Sponsor
- Ottawa Hospital Research Institute
- Provider of Information About this Clinical Study
- Overall Official(s)
- Christine A. Murphy, MClSc PhD(c), Principal Investigator, The Ottawa Hospital
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