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| ID | Type | Description | Link |
|---|---|---|---|
| 20/738-EC_P | Other Identifier | Ethics Committee of the Hospital Clínico San Carlos |
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| Name | Class |
|---|---|
| Yolanda García Álvarez | UNKNOWN |
| Francisco Javier Álvaro Afonso | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasounds once a week | Experimental | Patients will undergo the application of ultrasound therapy with a frequency of once a week. |
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| Ultrasounds once every two weeks | Experimental | Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks. |
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| Standard of care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Debridement | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastián Flores Escobar | Contact | 667857971 | +34 | jhflores@ucm.es |
| Francisco Javier Alvaro Afonso | Contact | 91 394 1535 | +34 | alvaro@ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| Yolanda García Álvarez | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense University | Recruiting | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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A randomized and controlled parallel clinical trial
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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.
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| Conventional Treatment | Procedure | Conventional Treatment based on international guidelines for diabetic foot |
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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 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |