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

Sponsor
Olaf Bakker
Study ID
NCT07251426
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • COLD ATMOSPHERIC PLASMA — DEVICE
    Cold Atmospheric plasma treatment in addition to standard wound care

Study Details

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.

Key Dates

First listed
Nov 26, 2025
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
May 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
494 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cold atmospheric Plasma
    Cold Atmospheric Plasma Treatment 2x per week
  • No Intervention: Standard Wound Care
    The use of standardized wound care 2x per week

Primary Outcome Measure

Ulcer-free survival days [ Time Frame: 26 weeks ]

Central Contacts

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