Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

NCT01973361 | Completed DMC

• 1 other identifier: 20130152-01H
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

WOUNDS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Protease activity

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

• Bacterial burden

  Pre-treatment, week 5 and week 12

• Number of wounds healed

  Throughout duration of the study

Study Arms (2)

Ultrasound debridement

EXPERIMENTAL

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

Device: Ultrasound debridement

Best Practice wound care

ACTIVE COMPARATOR

Participants receiving best practice wound care alone

Device: Best practice wound care

Interventions

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.

Also known as: Misonix Sonic One Ultrasound Wound Care System

Ultrasound debridement

Best practice wound care DEVICE

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

Best Practice wound care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Wound Healing Centre

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries; Diabetes Mellitus; Wound Infection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Study Officials

• Christine A. Murphy, MClSc PhD(c)

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

CA (1)