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Completed

NCT Number: NCT01973361

Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

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.

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Key information

Conditions

Wounds Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Nutritional and Metabolic Diseases Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital Wound Healing Centre

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound debridement

Device

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 names: Misonix Sonic One Ultrasound Wound Care System

Best practice wound care

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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

Acronym: UltraHeal

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2013
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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