NCT05577104

Wound Bed Preparation for Diabetic Foot Ulcers

The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
PROCEDURE	Negative pressure wound therapy (NPWT)	For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).
PROCEDURE	conventional moist dressings	For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-10
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China