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

Universidad Complutense de Madrid

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: Ultrasound Debridement; Procedure: Conventional Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04716790

20/738-EC_P (Other Identifier)

Ultrasound Debridement

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Ultrasounds once a week

Experimental group

Description:

Patients will undergo the application of ultrasound therapy with a frequency of once a week.

Treatment:

Procedure: Ultrasound Debridement

Ultrasounds once every two weeks

Experimental group

Description:

Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.

Treatment:

Procedure: Ultrasound Debridement

Standard of care

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Treatment