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

Primary Purpose

WOUNDS

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ultrasound debridement

Best practice wound care

About this trial

This is an interventional treatment trial for WOUNDS focused on measuring Wounds, Lower extremity, Diabetes, Arterial Insufficiency, Debridement, Low frequency ultrasound, Contact ultrasound, Wound clinic, Wound bed preparation, Wound infection, Chronic wound inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

The Ottawa Hospital Wound Healing Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound debridement

Best Practice wound care

Arm Description

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

Participants receiving best practice wound care alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

Full Information

NCT ID

NCT01973361

First Posted

October 25, 2013

Last Updated

October 21, 2015

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01973361

Brief Title

Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

WOUNDS

Keywords

Wounds, Lower extremity, Diabetes, Arterial Insufficiency, Debridement, Low frequency ultrasound, Contact ultrasound, Wound clinic, Wound bed preparation, Wound infection, Chronic wound inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound debridement

Arm Type

Experimental

Arm Description

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

Arm Title

Best Practice wound care

Arm Type

Active Comparator

Arm Description

Participants receiving best practice wound care alone

Intervention Type

Device

Intervention Name(s)

Ultrasound debridement

Other Intervention Name(s)

Misonix Sonic One Ultrasound Wound Care System

Intervention Description

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

Intervention Name(s)

Best practice wound care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in wound surface area

Description

The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.

Time Frame

Weekly for 4 weeks then at 12 weeks.

Secondary Outcome Measure Information:

Title

Protease activity

Description

Time Frame

Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.

Title

Bacterial burden

Description

Time Frame

Pre-treatment, week 5 and week 12

Title

Number of wounds healed

Description

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.

Time Frame

Throughout duration of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine A. Murphy, MClSc PhD(c)

Organizational Affiliation

The Ottawa Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital Wound Healing Centre

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

12. IPD Sharing Statement

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Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

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