WOUNDSUltraHealNCT01973361
Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing
A study testing Ultrasound debridement and Best practice wound care in people with WOUNDS, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- WOUNDS
- What is being tested?
- Ultrasound debridement and Best practice wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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].
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Ultrasound debridement, Best practice wound care
- Keywords
- Wounds, Lower extremity, Diabetes, Arterial Insufficiency, Debridement, Low frequency ultrasound, Contact ultrasound, Wound clinic, Wound bed preparation, Wound infection, Chronic wound inflammation
- Medical subject headings
- Wounds and Injuries, Diabetes Mellitus, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound debridementDevice
Also called Misonix Sonic One Ultrasound Wound Care System
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 careDevice
Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound debridement | Experimental | Participants receiving ultrasound assisted debridement in addition to best practice wound care. Receives: Device: Ultrasound debridement |
| Best Practice wound care | Active comparator | Participants receiving best practice wound care alone Receives: Device: Best practice wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 4 weeks then at 12 weeks.
Secondary outcomes (3)
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.
Measured: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
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
Measured: Pre-treatment, week 5 and week 12
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.
Measured: Throughout duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WOUNDSStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine A. Murphy, MClSc PhD(c), Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973361
- Sponsor's protocol ID
- 20130152-01H
- Acronym
- UltraHeal
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2013
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01973361
- Acronym / sponsor ID
- UltraHeal / 20130152-01H
- Conditions
- WOUNDS
- Keywords
- Wounds, Lower extremity, Diabetes, Arterial Insufficiency, Debridement, Low frequency ultrasound, Contact ultrasound, Wound clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound debridement | Experimental | Device: Ultrasound debridementParticipants receiving ultrasound assisted debridement in addition to best practice wound care. |
| Best Practice wound care | Active comparator | Device: Best practice wound careParticipants receiving best practice wound care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound debridementAlso: Misonix Sonic One Ultrasound Wound Care SystemUltrasound-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. | Device | Ultrasound debridement |
| Best practice wound careParticipants will receive moist wound care with addition of silver alginate dressing for visual cues of infection. | Device | Best Practice wound care |
Primary outcome
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.
3 secondary outcomes
Protease activity
Time frame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.
Bacterial burden
Time frame: Pre-treatment, week 5 and week 12
Number of wounds healed
Time frame: Throughout duration of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine A. Murphy, MClSc PhD(c) principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound debridement and Best practice wound care in people with WOUNDS, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound surface area (time frame: Weekly for 4 weeks then at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.