Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Healing Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Ultrasounds once a week
Patients will undergo the application of ultrasound therapy with a frequency of once a week.
Intervention: Ultrasound Debridement (Procedure)
Ultrasounds once every two weeks
Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.
Intervention: Ultrasound Debridement (Procedure)
Standard of care
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: Conventional Treatment (Procedure)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Transcutaneous oxygen pressure (TcPO2)(baseline and week 7)
- Health-related quality of life(baseline and 12 week)
- Wound Conditions(12 weeks)
- Pain intensity(12 weeks)
Investigators
Sebastian Flores Escobar
Principal Investigator
Universidad Complutense de Madrid