Diabetic Foot UlcerNCT04716790
Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).
A study testing Ultrasound Debridement and Conventional Treatment in people with Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Ultrasound Debridement and Conventional Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2021to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complutense University
Madrid, 28040
Sebastián Flores, 667857971 ext. +34, jhflores@ucm.es
About this study
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
The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Ultrasound Debridement, Conventional Treatment
- Keywords
- Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound DebridementProcedure or surgery
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.
Conventional TreatmentProcedure or surgery
Conventional Treatment based on international guidelines for diabetic foot
| Study group | Role | What they receive |
|---|---|---|
| Ultrasounds once a week | Experimental | Patients will undergo the application of ultrasound therapy with a frequency of once a week. Receives: 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. Receives: 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. Receives: Procedure: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
Total epithelialization of the wound.
Measured: 12 weeks
Healing Time
Time from the inclusion of the wound in the study until its total epithelialization.
Measured: 12 weeks
Wound Size
Planimetric measurements of wound size will be made using Visitrak (Smith \& Nephew, Hull, UK).
Measured: 12 weeks
Secondary outcomes (4)
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).
Measured: 12 weeks
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.
Measured: baseline and week 7
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
Measured: 12 weeks
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.
Measured: baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start20 Apr 2021
- Primary completion18 Jan 2022 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized and controlled parallel clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Yolanda García Álvarez, Francisco Javier Álvaro Afonso
- Responsible party
- Principal investigator, Sebastian Flores Escobar, Universidad Complutense de Madrid
- Investigators
- Yolanda García Álvarez, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716790
- Sponsor's protocol ID
- Ultrasound Debridement
- Other IDs
- 20/738-EC_P
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04716790
- Acronym / sponsor ID
- Ultrasound Debridement
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Yolanda García Álvarez, Francisco Javier Álvaro Afonso
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 18 Jan 2022 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A randomized and controlled parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasounds once a week | Experimental | Procedure: Ultrasound DebridementPatients will undergo the application of ultrasound therapy with a frequency of once a week. |
| Ultrasounds once every two weeks | Experimental | Procedure: Ultrasound DebridementPatients will undergo the application of ultrasound therapy with a frequency of once every two weeks. |
| Standard of care | Active comparator | Procedure: Conventional TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound DebridementUltrasounds 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. | Procedure or surgery | Ultrasounds once a week, Ultrasounds once every two weeks |
| Conventional TreatmentConventional Treatment based on international guidelines for diabetic foot | Procedure or surgery | Standard of care |
Primary outcome
Healing Rate
Time frame: 12 weeks
Total epithelialization of the wound.
Healing Time
Time frame: 12 weeks
Time from the inclusion of the wound in the study until its total epithelialization.
Wound Size
Time frame: 12 weeks
Planimetric measurements of wound size will be made using Visitrak (Smith \& Nephew, Hull, UK).
4 secondary outcomes
Wound Conditions
Time frame: 12 weeks
Transcutaneous oxygen pressure (TcPO2)
Time frame: baseline and week 7
Pain intensity
Time frame: 12 weeks
Health-related quality of life
Time frame: baseline and 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda García Álvarez principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Debridement and Conventional Treatment in people with Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastián Flores Escobar (667857971 ext. +34, jhflores@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.