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Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).

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ClinicalTrials.gov Identifier: NCT04716790
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : February 23, 2021
Sponsor:
Collaborators:
Yolanda García Álvarez
Francisco Javier Álvaro Afonso
Information provided by (Responsible Party):
Sebastian Flores Escobar, Universidad Complutense de Madrid

Study Description
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Brief Summary:
The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Procedure: Ultrasound Debridement Procedure: Conventional Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized and controlled parallel clinical trial
Masking: Single (Investigator)
Masking Description: The clinician who performs the cures, photographs and data collection is different from the clinician who performs the application of ultrasound debridement. Therefore, the evaluator will be blinded.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : January 18, 2022
Estimated Study Completion Date : June 23, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasounds once a week
Patients will undergo the application of ultrasound therapy with a frequency of once a week.
 Procedure: 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.
Experimental: Ultrasounds once every two weeks
Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.
 Procedure: 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.
Active Comparator: 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.
 Procedure: Conventional Treatment
Conventional Treatment based on international guidelines for diabetic foot


Outcome Measures
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Primary Outcome Measures :
  1. Healing Rate [ Time Frame: 12 weeks ]
    Total epithelialization of the wound.

  2. Healing Time [ Time Frame: 12 weeks ]
    Time from the inclusion of the wound in the study until its total epithelialization.

  3. Wound Size [ Time Frame: 12 weeks ]
    Planimetric measurements of wound size will be made using Visitrak (Smith & Nephew, Hull, UK).


Secondary Outcome Measures :
  1. Wound Conditions [ Time Frame: 12 weeks ]
    The wound bed tissue will be evaluated for the presence, quality and consistency of the granulation tissue using a validated wound scoring system, with scores ranging from a minimum of zero points to a maximum of seven points (Wollina Score).

  2. Transcutaneous oxygen pressure (TcPO2) [ Time Frame: baseline and week 7 ]
    Two measurements will be made, one at the initial visit and the other at the final visit, and possible variations will be assessed.

  3. Pain intensity [ Time Frame: 12 weeks ]
    It will be assessed using a numerical scale of pain that receives values between zero and ten, understanding zero as the absence of pain and ten as the maximum pain bearable by the patient

  4. Health-related quality of life [ Time Frame: baseline and 12 week ]
    It will be assessed using the SF-36 health-related quality of life questionnaire at the beginning and end of the study. This questionnaire receives values between zero and one hundred so that the higher the score, the better the patient's health status.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients ≥18 years old.
  • 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:

  • Critical limb ischemia patients with ABI≤0.5 and ASBP<70mmHg or TSBP<50mmHg.
  • 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)
Contacts and Locations
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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): NCT04716790


Contacts
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Contact: Sebastián Flores Escobar 667857971 ext +34 jhflores@ucm.es

Sponsors and Collaborators
Universidad Complutense de Madrid
Yolanda García Álvarez
Francisco Javier Álvaro Afonso
More Information
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Responsible Party: Sebastian Flores Escobar, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04716790    
Other Study ID Numbers: Ultrasound Debridement
20/738-EC_P ( Other Identifier: Ethics Committee of the Hospital Clínico San Carlos )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sebastian Flores Escobar, Universidad Complutense de Madrid:
Diabetic Foot
Diabetic Foot Ulcer
Ultrasound Debridement
Ultrasonic Debridement
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases