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

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Conventional Treatment; Procedure: Ultrasound Debridement

• Registration Number: NCT04716790
• Lead Sponsor: Universidad Complutense de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Status Verified: 2021-04
• Study Start: 2021-04-20
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2022-01-18
• Study Completion: 2023-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Conventional Treatment	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.
Ultrasounds once a week	Ultrasound Debridement	Patients will undergo the application of ultrasound therapy with a frequency of once a week.
Ultrasounds once every two weeks	Ultrasound Debridement	Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.

Primary Outcome Measures

Name	Time	Method
Healing Rate	12 weeks	Total epithelialization of the wound.
Healing Time	12 weeks	Time from the inclusion of the wound in the study until its total epithelialization.
Wound Size	12 weeks	Planimetric measurements of wound size will be made using Visitrak (Smith \& Nephew, Hull, UK).

Secondary Outcome Measures

Name	Time	Method
Transcutaneous oxygen pressure (TcPO2)	baseline and week 7	Two measurements will be made, one at the initial visit and the other at the final visit, and possible variations will be assessed.
Health-related quality of life	baseline and 12 week	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.
Wound Conditions	12 weeks	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).
Pain intensity	12 weeks	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

Trial Locations

Locations (1)

Complutense University; 🇪🇸 Madrid, Spain