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

Ottawa Hospital Research Institute

Status: Completed

Conditions: WOUNDS

Treatments: Device: Ultrasound debridement; Device: Best practice wound care

Study type: Interventional

Funder types: Other

Identifiers

NCT01973361

20130152-01H

Details and patient eligibility

About

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 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Ultrasound debridement

Experimental group

Description:

Participants receiving ultrasound assisted debridement in addition to best practice wound care.

Treatment:

Device: Ultrasound debridement

Best Practice wound care

Active Comparator group

Description:

Participants receiving best practice wound care alone

Treatment:

Device: Best practice wound care