Wound Bed Preparation for Diabetic Foot Ulcers

Status Recruiting

Clinical Trial Summary

The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.

Clinical Trial Description

The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs. This ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05577104
Study type	Interventional
Source	Nanjing First Hospital, Nanjing Medical University
Contact	Yin Wu, phD
Phone	18305155832
Email	medwuyin@163.com
Status	Recruiting
Phase	N/A
Start date	May 1, 2022
Completion date	December 10, 2022

View Details

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