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

Primary Purpose

Diabetic Foot Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Ultrasound Debridement

Conventional Treatment

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Complutense UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasounds once a week

Ultrasounds once every two weeks

Standard of care

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Healing Rate

Total epithelialization of the wound.

Healing Time

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

Wound Size

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

Secondary Outcome Measures

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).

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.

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

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.

Full Information

NCT ID

NCT04716790

First Posted

January 15, 2021

Last Updated

April 26, 2021

Sponsor

Universidad Complutense de Madrid

Collaborators

Yolanda García Álvarez, Francisco Javier Álvaro Afonso

1. Study Identification

Unique Protocol Identification Number

NCT04716790

Brief Title

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

Official Title

Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

January 18, 2022 (Anticipated)

Study Completion Date

June 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Complutense de Madrid

Collaborators

Yolanda García Álvarez, Francisco Javier Álvaro Afonso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized and controlled parallel clinical trial

Masking

Investigator

Masking Description

The clinician who performs the cures, photographs and data collection is different from the clinician who performs the application of ultrasound debridement. Therefore, the evaluator will be blinded.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasounds once a week

Arm Type

Experimental

Arm Description

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

Arm Title

Ultrasounds once every two weeks

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of care

Arm Type

Active Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Debridement

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Conventional Treatment

Intervention Description

Conventional Treatment based on international guidelines for diabetic foot

Primary Outcome Measure Information:

Title

Healing Rate

Description

Total epithelialization of the wound.

Time Frame

12 weeks

Title

Healing Time

Description

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

Time Frame

12 weeks

Title

Wound Size

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Wound Conditions

Description

Time Frame

12 weeks

Title

Transcutaneous oxygen pressure (TcPO2)

Description

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

Title

Pain intensity

Description

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

Title

Health-related quality of life

Description

Time Frame

baseline and 12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastián Flores Escobar

Phone

667857971

Ext

+34

jhflores@ucm.es

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco Javier Alvaro Afonso

Phone

91 394 1535

Ext

+34

alvaro@ucm.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yolanda García Álvarez

Organizational Affiliation

Universidad Complutense de Madrid

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complutense University

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastián Flores

Phone

667857971

Ext

+34

jhflores@ucm.es

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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