NCT04716790

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

January 15, 2021

Last Update Submit

April 26, 2021

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic FootDiabetic Foot UlcerUltrasound DebridementUltrasonic Debridement

Outcome Measures

Primary Outcomes (3)

  • Healing Rate

    Total epithelialization of the wound.

    12 weeks

  • Healing Time

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

    12 weeks

  • Wound Size

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

    12 weeks

Secondary Outcomes (4)

  • Wound Conditions

    12 weeks

  • Transcutaneous oxygen pressure (TcPO2)

    baseline and week 7

  • Pain intensity

    12 weeks

  • Health-related quality of life

    baseline and 12 week

Study Arms (3)

Ultrasounds once a week

EXPERIMENTAL

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

Procedure: Ultrasound Debridement

Ultrasounds once every two weeks

EXPERIMENTAL

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

Procedure: Ultrasound Debridement

Standard of care

ACTIVE COMPARATOR

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.

Procedure: Conventional Treatment

Interventions

Ultrasound DebridementPROCEDURE

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.

Ultrasounds once a weekUltrasounds once every two weeks
Conventional TreatmentPROCEDURE

Conventional Treatment based on international guidelines for diabetic foot

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complutense University

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Yolanda García Álvarez

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastián Flores Escobar

CONTACT

667857971jhflores@ucm.es

Francisco Javier Alvaro Afonso

CONTACT

91 394 1535alvaro@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized and controlled parallel clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

April 20, 2021

Primary Completion

January 18, 2022

Study Completion

June 23, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)