Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

NCT ID: NCT01973361

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

WOUNDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultrasound debridement

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

Group Type: EXPERIMENTAL

Ultrasound debridement

Intervention Type: DEVICE

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.

Best Practice wound care

Participants receiving best practice wound care alone

Group Type: ACTIVE_COMPARATOR

Best practice wound care

Intervention Type: DEVICE

Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.

Interventions

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.

Intervention Type: DEVICE

Best practice wound care

Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.

Intervention Type: DEVICE

Other Intervention Names

Misonix Sonic One Ultrasound Wound Care System

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine A. Murphy, MClSc PhD(c)

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital Wound Healing Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20130152-01H

Identifier Type: -

Identifier Source: org_study_id