Status:
UNKNOWN
Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Yolanda García Álvarez
Francisco Javier Álvaro Afonso
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
- 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
- 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)
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04716790
Start Date
April 20 2021
End Date
June 23 2023
Last Update
April 28 2021
Active Locations (1)
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1
Complutense University
Madrid, Spain, 28040