Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-06 @ 5:12 AM
Study NCT ID:
NCT01973361
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2013-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-02', 'releaseDate': '2017-05-08'}], 'estimatedResultsFirstSubmitDate': '2017-05-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in wound surface area', 'timeFrame': 'Weekly for 4 weeks then at 12 weeks.', 'description': 'The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.'}], 'secondaryOutcomes': [{'measure': 'Protease activity', 'timeFrame': 'Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.', 'description': '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.'}, {'measure': 'Bacterial burden', 'timeFrame': 'Pre-treatment, week 5 and week 12', 'description': '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'}, {'measure': 'Number of wounds healed', 'timeFrame': 'Throughout duration of the study', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Wounds', 'Lower extremity', 'Diabetes', 'Arterial Insufficiency', 'Debridement', 'Low frequency ultrasound', 'Contact ultrasound', 'Wound clinic', 'Wound bed preparation', 'Wound infection', 'Chronic wound inflammation'], 'conditions': ['WOUNDS']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons with lower extremity wound referred to vascular surgery service.\n* Full thickness wound below the knee with surface area of at least 1cm2.\n* Age \\>18 years\n* English speaking\n* Ulcer of known etiology including diabetic foot wounds, and arterial or venous leg ulcers\n* Willing and able to adhere to 12 week study protocol that includes attending weekly clinic appointments, and wearing prescribed footwear or compression therapy\n\nExclusion Criteria:\n\n* Leg wounds due to inflammatory conditions (e.g. pyoderma gangrenosum, vasculitis), malignancy, or other unknown etiologies.\n* Severe arterial insufficiency: Absence of pedal pulses combined with Ankle Brachial Index ≤ 0.3, Toe Pressure ≤20, or Trans Cutaneous Oxygen Measure ≤20\n* Presence of acute limb threatening infection\n* Vascular surgery planned within next 3 months\n* Exposed vascular graft or blood vessel, bone or tendon in the base of the wound.\n* Currently receiving advanced wound therapy treatments: Hyperbaric therapy, biological dressings \\[collagen or extracellular matrix dressings\\].\n* Increased likelihood of an adverse reaction to ultrasonic debridement due to:\n* Excessive wound pain (\\>5 VAS scale) or patient described intolerable\n* Allergy to topical anesthetic (lidocaine)\n* Individuals who have factors/circumstances that are known to limit their ability to demonstrate healing in 4 weeks.\n\nFor example:\n\n* medically unstable or palliative medical status\n* poor nutritional status (low serum albumin \\< 15),\n* anemia (Hb \\< 75 mg/dl),\n* taking immunosuppressant medication (prednisone, chemotherapy; transplant anti-rejection medication),\n* Individuals with medical conditions that contraindicate the use of ultrasound energy\n* Cardiac pacemaker or defibrillator\n* Excessive bleeding tendency (\\> 5 mins post debridement) or identified coagulopathic disorders\n* Exposed bone in the wound base\n* Untreated osteomyelitis'}, 'identificationModule': {'nctId': 'NCT01973361', 'acronym': 'UltraHeal', 'briefTitle': 'Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20130152-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound debridement', 'description': 'Participants receiving ultrasound assisted debridement in addition to best practice wound care.', 'interventionNames': ['Device: Ultrasound debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Practice wound care', 'description': 'Participants receiving best practice wound care alone', 'interventionNames': ['Device: Best practice wound care']}], 'interventions': [{'name': 'Ultrasound debridement', 'type': 'DEVICE', 'otherNames': ['Misonix Sonic One Ultrasound Wound Care System'], '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.', 'armGroupLabels': ['Ultrasound debridement']}, {'name': 'Best practice wound care', 'type': 'DEVICE', 'description': 'Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.', 'armGroupLabels': ['Best Practice wound care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Wound Healing Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Christine A. Murphy, MClSc PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-08', 'type': 'RELEASE'}, {'date': '2017-10-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ottawa Hospital Research Institute'}}}}