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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04716790
Other study ID # Ultrasound Debridement
Secondary ID 20/738-EC_P
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2021
Est. completion date June 23, 2023

Study information

Verified date April 2021
Source Universidad Complutense de Madrid
Contact Sebastián Flores Escobar
Phone 667857971
Email jhflores@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 23, 2023
Est. primary completion date January 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.
Conventional Treatment
Conventional Treatment based on international guidelines for diabetic foot

Locations

Country Name City State
Spain Complutense University Madrid

Sponsors (3)

Lead Sponsor Collaborator
Universidad Complutense de Madrid Francisco Javier Álvaro Afonso, Yolanda García Álvarez

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing Rate Total epithelialization of the wound. 12 weeks
Primary Healing Time Time from the inclusion of the wound in the study until its total epithelialization. 12 weeks
Primary Wound Size Planimetric measurements of wound size will be made using Visitrak (Smith & Nephew, Hull, UK). 12 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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