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

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ClinicalTrials.gov Identifier: NCT01973361
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
WOUNDS Device: Ultrasound debridement Device: Best practice wound care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound debridement
Participants receiving ultrasound assisted debridement in addition to best practice wound care.
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.
Other Name: Misonix Sonic One Ultrasound Wound Care System

Active Comparator: Best Practice wound care
Participants receiving best practice wound care alone
Device: Best practice wound care
Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Protease activity [ Time Frame: Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks. ]
    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.

  2. Bacterial burden [ Time Frame: Pre-treatment, week 5 and week 12 ]
    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

  3. Number of wounds healed [ Time Frame: Throughout duration of the study ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973361


Locations
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Canada, Ontario
The Ottawa Hospital Wound Healing Centre
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Christine A. Murphy, MClSc PhD(c) The Ottawa Hospital

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01973361     History of Changes
Other Study ID Numbers: 20130152-01H
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Ottawa Hospital Research Institute:
Wounds
Lower extremity
Diabetes
Arterial Insufficiency
Debridement
Low frequency ultrasound
Contact ultrasound
Wound clinic
Wound bed preparation
Wound infection
Chronic wound inflammation

Additional relevant MeSH terms:
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Wounds and Injuries