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

Universidad Complutense de Madrid60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Ultrasound DebridementPROCEDURE

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 TreatmentPROCEDURE

Conventional Treatment based on international guidelines for diabetic foot

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Complutense University

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Healing Rate

Total epithelialization of the wound.

Time frame: 12 weeks

Healing Time

Time from the inclusion of the wound in the study until its total epithelialization.

Time frame: 12 weeks

Wound Size

Planimetric measurements of wound size will be made using Visitrak (Smith \& Nephew, Hull, UK).

Time frame: 12 weeks

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: 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.

Central Contacts

Sebastián Flores Escobar

CONTACT

667857971 jhflores@ucm.es

Francisco Javier Alvaro Afonso

CONTACT

91 394 1535 alvaro@ucm.es

Data from ClinicalTrials.gov

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