Clinical trial NCT04633642: Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
Official title: Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: ultrasound assisted wound debridement
surgical debridement
cellular proliferation
microbiology
diabetic foot ulcers
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Francisco Javier Álvaro Afonso
name: David Sevillano Fernández
name: Yolanda García Álvarez
name: Irene Sanz Corbalan
name: Esther García Morales
First posted: 2020-11-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized and controlled parallel clinical trial
Primary purpose: TREATMENT

Brief summary: The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period.

Detailed description: 2. Methods

2.1. Trial design

A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019. The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos, Madrid, Spain (C.P. - C.I. 16/484-P). Each patient provided written informed consent before inclusion.

2.1. Intervention

Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period.

Soft tissue punch biopsies (3mm) were taken after wound debridement sessions at week zero and week six.

2.2. Follow-up Patients were followed-up for 6 months after inclusion. During the follow-up period, the investigators recorded ulcer healing. Ulcer healing was defined as complete epithelialization without any sustained drainage up to 24 weeks after the end of the study follow-up.

2.3. Sample size The sample size was calculated using the Granmo v.12 program (Municipal Institute of Medical Research, Barcelona, Spain) (https://www.imim.cat/ofertadeserveis/software-public/granmo/ ). Therefore, we analyzed 51 patients (24 in surgical group and 27 en UAW group) with an alpha of 0.05 and a statistical power of 0.80.

2.4. Randomization A computer-generated random number table was used to carry out the randomization of the patients into the two groups by an investigator who was blinded to the identity of the participants.

2.5. Blinding None of the participants, care providers, and outcome adjudicators was blinded to the interventions after assignment.

2.6. Statistical Analysis Statistical analysis was performed using SPSS for IOs version 21.0 (SPSS, Inc. Chicago, IL, USA). The assumption of normality of all continuous variables was verified using the Kolmogorov-Smirnov test. Statistical differences between groups were calculated using the Chi-Square test and, where appropriate, Fisher's exact test for categorical variables. The Mann-Whitney U test was performed for abnormally distributed quantitative parameters, and Student's t-test was performed for quantitative variables that were distributed normally. The criteria of p \< 0.05 was accepted as statistically significant with a confidence interval of 95%.

This study was conducted in accordance with the Declaration of Helsinki (2013 revision) and followed all local laws and regulations in clinical research investigations in patients.

Eligibility criteria: Inclusion Criteria:

* • Male and female patients ≥18 years old

  * Type 1 or type 2 diabetes with levels of HbA1c≤85.8 mmol/mol (10%) within 30 days of the beginning of the study
  * Wound stages IB, IIB, ID, and IID according to the University of Texas Diabetic Wound Classification \[11\]
  * Wound duration of 1-24 months
  * Wound size between 1-30 cm2 after debridement
  * Clinical picture of wounds showing mild or moderate infection, according to the criteria of the Infectious Disease Society of America Guidelines \[12\] and the European Wound Management Association (EWMA) \[13\]
  * 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:

* • Chronic renal disease or dialysis

  * Non-treated osteomyelitis
  * Necrotizing soft tissue infections
  * Critical limb ischaemia patients with ABI≤0.5 and ASBP\<70mmHg or \<50mmHg
  * Life expectancy \<6 months due to malignant DFU
  * Pregnancy and lactation
  * Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
  * Patients showing local or systemic conditions that may impair tissue repair

Primary outcomes:
measure: Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks
timeFrame: At week zero and week 6
measure: Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks
timeFrame: At week zero and week 6
measure: Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks
timeFrame: At week zero and week 6
Secondary outcomes:
measure: Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g)
timeFrame: At week zero and week 6
measure: Wound Score at 6 Weeks
timeFrame: Six weeks
measure: Wound Size
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fancisco Javier Álvaro Afonso
city: Madrid
country: Spain
facility: José Luis Lázaro Martínez
Study officials:
affiliation: Universidad Complutense de Madrid
name: Lázaro Martinez, Professor
role: PRINCIPAL_INVESTIGATOR
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