N/A
Completed N=51
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
Source: ClinicalTrials.gov NCT04633642 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks — 2.82; 1.77 score on a scale — p=<0.01
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.
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 |
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
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. Informational only — not medical advice.