N/A N=51 Randomized Single-blind Treatment

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

Diabetic Foot Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT04633642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks — 2.82; 1.77 score on a scale — p=<0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ultrasound group (Procedure); Surgical group (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universidad Complutense de Madrid
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks	2.82; 1.77	<0.01 sig
PRIMARY Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks	2.81; 1.20	<0.01 sig
PRIMARY Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks	2.56; 2.00	<0.01 sig
SECONDARY Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g)	2.11; 4.39	0.01 sig
SECONDARY Wound Score at 6 Weeks	5.4; 5.6	0.93
SECONDARY Wound Size	1.0; 0.88	0.711

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04633642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.