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

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

Official Title
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Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Procedure: Ultrasound Debridement
* Procedure: Conventional Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized and controlled parallel clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasounds once a week<br>Patients will undergo the application of ultrasound therapy with a frequency of once a week. | Procedure: Ultrasound Debridement<br>* 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.<br>|
| Experimental: Ultrasounds once every two weeks<br>Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks. | Procedure: Ultrasound Debridement<br>* 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.<br>|
| Active Comparator: Standard of care<br>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<br>* Conventional Treatment based on international guidelines for diabetic foot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Rate | Total epithelialization of the wound. | 12 weeks | 
| Healing Time | Time from the inclusion of the wound in the study until its total epithelialization. | 12 weeks | 
| Wound Size | Planimetric measurements of wound size will be made using Visitrak (Smith & Nephew, Hull, UK). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Conditions | 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). | 12 weeks | 
| Transcutaneous oxygen pressure (TcPO2) | Two measurements will be made, one at the initial visit and the other at the final visit, and possible variations will be assessed. | baseline and week 7 | 
| Pain intensity | 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 | 12 weeks | 
| Health-related quality of life | 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. | baseline and 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement