NCT04633642

Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)

Completed NA Results posted Last updated 14 July 2021

What this trial tests

NA trial testing Ultrasound group in Diabetic Foot Ulcer in 51 participants. Completed in 31 December 2019.

Timeline

1 November 2017

Primary endpoint
1 November 2018

31 December 2019

Quick facts

Lead sponsor	Universidad Complutense de Madrid
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	51
Start date	1 November 2017
Primary completion	1 November 2018
Estimated completion	31 December 2019
Sites	2 locations across Spain

Drugs / interventions tested

• Ultrasound group
• Surgical group

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Universidad Complutense de Madrid — full company profile →

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks Primary · At week zero and week 6

Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels). Higher scores mean a better outcome

Group	Value	95% CI
Ultrasound Group (UAW Group)	2.82	± 0.52
Surgical Group	1.77	± 1.30

Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks Primary · At week zero and week 6

Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome.

Group	Value	95% CI
Ultrasound Group (UAW Group)	2.81	± 0.48
Surgical Group	1.20	± 0.26

Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks Primary · At week zero and week 6

Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity)

Group	Value	95% CI
Ultrasound Group (UAW Group)	2.56	± 0.89
Surgical Group	2.00	± 0.10

Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g) Secondary · At week zero and week 6

Tissue samples were weighed and mechanically homogenised in 0.5ml volumes of sterile phosphate buffered saline (PBS, Sigma Aldrich, St Louis, MO). Homogenates were diluted and plated onto Columbia agar (BD, Sparks, MD), Columbia agar supplemented with colistin and nalidixic acid (BD), MacConkey agar (BD), and Sabouraud dextrose agar (BD) using a spiral plater workstation (Don Whitley Scientific, Shipley, UK).The limit of detection was 10 colony-forming units (CFU). Results were expressed as CFU per gram of tissue (CFU/g). Isolated microorganisms were identified by standard criteria and the BBL

Group	Value	95% CI
Ultrasound Group (UAW Group)	2.11	± 0.8
Surgical Group	4.39	± 1.24

Wound Score at 6 Weeks Secondary · Six weeks

Wound bed tissue was evaluated for presence, quality, and consistency of granulation tissue using a validated wound scoring system, with scores ranging between a minimum of zero points and maximum of seven points. Higher scores mean a better outcome.

Group	Value	95% CI
Ultrasound Group (UAW Group)	5.4	± 1.5
Surgical Group	5.6	± 0.7

Wound Size Secondary · 6 weeks

A planimetric measurements of wound size were conducted using Visitrak (Smith \& Nephew, Hull, UK), with the area of the lesion determined with an approximation of ±5mm2

Group	Value	95% CI
Ultrasound Group (UAW Group)	1.0	± 1.22
Surgical Group	0.88	± 1.04

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound-Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): An Open-Label Randomized Controlled Trial.
   Lázaro-Martínez JL, Álvaro-Afonso FJ, Sevillano-Fernández D, García-Álvarez Y, et al · · 2020 · cited 25× · PMID 33322200 · DOI 10.3390/jcm9124032
2. The Potential of Mesenchymal Stem/Stromal Cells in Diabetic Wounds and Future Directions for Research and Therapy-Is It Time for Use in Everyday Practice?
   Sieńko D, Szabłowska-Gadomska I, Nowak-Szwed A, Rudziński S, et al · · 2024 · cited 6× · PMID 39596237 · DOI 10.3390/ijms252212171