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

Last updated: April 26, 2021
Sponsor: Universidad Complutense de Madrid
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Pressure Ulcer

Ulcers

Treatment

N/A

Clinical Study ID

NCT04716790
Ultrasound Debridement
20/738-EC_P
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 TexasClassification.
  • DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderateinfection, 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, ortoe systolic blood pressure (TSBP) ≥50mmHg, ABI>0.9, TSBP ≥50mmHg and toe-brachialindex (TBI) ≤0.7

Exclusion

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 usingeffective contraception.
  • Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)

Study Design

Total Participants: 60
Study Start date:
April 20, 2021
Estimated Completion Date:
June 23, 2023

Connect with a study center

  • Complutense University

    Madrid, 28040
    Spain

    Active - Recruiting

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