Diabetic Foot Ulcer
Conditions
Keywords
Diabetic Foot, Diabetic Foot Ulcer, Ultrasound Debridement, Ultrasonic Debridement
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.
Interventions
PROCEDUREUltrasound Debridement
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.
PROCEDUREConventional Treatment
Conventional Treatment based on international guidelines for diabetic foot
Sponsors
Yolanda García Álvarez
Francisco Javier Álvaro Afonso
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Intervention model description
A randomized and controlled parallel clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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 |
Countries
Spain
Contacts
Primary ContactSebastián Flores Escobar
Backup ContactFrancisco Javier Alvaro Afonso
Outcome results
None listed