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

Diabetic Foot Ulcer Clinical Trial

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

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
• 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
• 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)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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