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

NCT07251426 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer

Interventions

DEVICE

COLD ATMOSPHERIC PLASMA

Cold Atmospheric plasma treatment in addition to standard wound care

Sponsors & Collaborators

  • Olaf Bakker

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2028-05-30
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251426 on ClinicalTrials.gov