Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

WOUNDS Clinical Trial

— UltraHeal  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973361
• Other study ID #: 20130152-01H
• Status: Completed
• Phase: N/A
• First received: October 25, 2013
• Last updated: October 21, 2015
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• WOUNDS
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Wound Healing Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wound surface area	The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.	Weekly for 4 weeks then at 12 weeks.
Secondary	Protease activity	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.	Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
Secondary	Bacterial burden	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	Pre-treatment, week 5 and week 12
Secondary	Number of wounds healed	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.	Throughout duration of the study