Clinical trial NCT01973361: Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: WOUNDS
Keywords: Wounds
Lower extremity
Diabetes
Arterial Insufficiency
Debridement
Low frequency ultrasound
Contact ultrasound
Wound clinic
Wound bed preparation
Wound infection
Chronic wound inflammation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in wound surface area
timeFrame: Weekly for 4 weeks then at 12 weeks.
Secondary outcomes:
measure: Protease activity
timeFrame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
measure: Bacterial burden
timeFrame: Pre-treatment, week 5 and week 12
measure: Number of wounds healed
timeFrame: Throughout duration of the study
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Wound Healing Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Christine A. Murphy, MClSc PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: