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

Ottawa Hospital Research Institute1 site in 1 country78 target enrollmentDecember 2013

ConditionsWOUNDS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: WOUNDS
Sponsor: Ottawa Hospital Research Institute
Enrollment: 78
Locations: 1
Primary Endpoint: Change in wound surface area
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ottawa Hospital Research Institute

Responsible Party

Sponsor

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 1cm
•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.

Outcomes

Primary Outcomes

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 Outcomes

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