Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).
NCT ID: NCT04716790
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-04-20
2023-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ultrasounds once a week
Patients will undergo the application of ultrasound therapy with a frequency of once a week.
Ultrasound Debridement
Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
Ultrasounds once every two weeks
Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.
Ultrasound Debridement
Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
Standard of care
Patients will be treated using the conventional treatment established by the protocol of the Diabetic Foot Unit of the University Podiatry Clinic of Complutense University of Madrid.
Conventional Treatment
Conventional Treatment based on international guidelines for diabetic foot
Interventions
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Ultrasound Debridement
Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
Conventional Treatment
Conventional Treatment based on international guidelines for diabetic foot
Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes mellitus with HbA1c ≤ 10%.
* DFU grades IA, IIA, IB, IIB, IC, IIC, ID, IID, according to the University of Texas Classification.
* DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderate infection, according to the PEDIS-IDSA Classification.
* Wound size between 1 cm² and 30 cm².
* Evolution time DFU between 1 and 24 months.
* Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI\>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7
Exclusion Criteria
* Clinical suspicion of osteomyelitis.
* Pregnant or lactating women or women of childbearing potential who are not using effective contraception.
* Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
18 Years
ALL
No
Sponsors
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Yolanda García Álvarez
UNKNOWN
Francisco Javier Álvaro Afonso
UNKNOWN
Universidad Complutense de Madrid
OTHER
Responsible Party
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Sebastian Flores Escobar
Principal Investigator
Principal Investigators
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Yolanda García Álvarez
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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Complutense University
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20/738-EC_P
Identifier Type: OTHER
Identifier Source: secondary_id
Ultrasound Debridement
Identifier Type: -
Identifier Source: org_study_id
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