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NOT YET RECRUITING
NCT07251426
NA

Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS

Sponsor: Olaf Bakker

View on ClinicalTrials.gov

Summary

Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. This is mainly due to a prolonged treatment duration, high recurrence rates and substantial healthcare costs in wound care. Current guidelines exist that outline the standard wound care (SWC) in these patient groups but it often fails to achieve timely healing. Cold atmospheric plasma (CAP) is an emerging technology with promising antimicrobial and wound healing properties. In vitro and in vivo studies have highlighted the ability of CAP to reduce the bacterial biofilm load and stimulate tissue regeneration and microcirculation. This Randomized Controlled Trial (RCT) aims to evaluate the clinical effectiveness and cost-effectiveness of CAP in addition to SWC in patients with a DFU and VLU.

Official title: Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS - a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

494

Start Date

2025-11-30

Completion Date

2028-11-30

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

DEVICE

COLD ATMOSPHERIC PLASMA

Cold Atmospheric plasma treatment in addition to standard wound care