We aimed to evaluate the effects of ultrasound-assisted wound (UAW) debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers (DFU) as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving 51 outpatients with complicated diabetic foot ulcers that either received surgical debridement (n = 24) or UAW debridement (n = 27) every week during a six-week treatment period. Compared to patients receiving surgical debridement, patients treated with UAW debridement exhibited significantly improved cellular proliferation, as determined by CD31 staining, Masson’s trichrome staining, and actin staining.
Bacterial loads were significantly reduced in the UAW debridement group compared to the surgical group (UAW group 4.27 ± 0.37 day 0 to 2.11 ± 0.8 versus surgical group 4.66 ± 1.21 day 0 to 4.39 ± 1.24 day 42; p = 0.01). Time to healing was also significantly lower (p = 0.04) in the UAW group (9.7 ± 3.8 weeks) compared to the surgical group (14.8 ± 12.3 weeks), but both groups had similar rates of patients that were healed after six months of follow-up (23 patients (85.1%) in the UAW group vs. 20 patients (83.3%) in the surgical group; p = 0.856). We propose that UAW debridement could be an effective alternative when surgical debridement is not available or is contraindicated for use on patients with complicated diabetic foot ulcers. [READ MORE]
Standard of care in patients with diabetic foot ulcers includes pressure off-loading, treatment of infection, restoration of tissue perfusion, metabolic control of diabetes, treatment of co-morbidities and local ulcer care .Wound debridement is a fundamental part of wound bed preparation (WBP) during diabetic foot ulcer (DFU) treatment. Regular wound debridement helps to eliminate biofilms from the wound bed, as well as remove necrotic tissue that may favor biofilm re-growth [2,3].While surgical debridement is considered the gold standard in DFU treatment and should be utilized over other techniques, it is not always available, practical or suitable or for each patient [4,5].
When considering co-morbidities, vascular status, level of infection, ulcer location, and patient preference, practitioners may find that alternative debridement methods are more appropriate as the primary treatment or in tandem with other treatments over time. Likewise, surgical debridement has certain limitations: it is not ideal for patients with poor vascular status; it requires specific surgical skills; for the procedure is required an operating room; and surgical debridement has the potential for large damage to wound beds with exposure bone, joint tissue or ligament . [READ MORE]
2.1. Trial Design
An open-label randomized and controlled parallel clinical trial was performed involving 51 outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019. This study protocol received full approval from the local Ethics Committee of the Hospital Clínico San Carlos, Madrid, Spain (C.P.-C.I. 16/484-P). All patients provided written informed consent before inclusion. The present study was registered retrospectively in ClinicalTrial.gov (Registration no.: NCT04633642). [READ MORE]
The surgical debridement group consisted of 24 patients and the UAW group consisted of 27 patients. Table 1 depicts clinical and demographic characteristics of both groups in our study population. [READ MORE]
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