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

ConditionsDiabetic Foot UlcerVenous Leg Ulcer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlaf Bakker

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and

Disqualifiers

extreme exudative wounds, i.e. wounds in which moisture is visible within seconds after patting dry;

any implanted active electronic device, such as a pacemaker, is present;

an electronic medical device attached to the body, for example electronic life support equipment, a hearing aid, insulin pump or dialysis machine. If this medical device can be disconnected, PLASOMA treatment may be performed. If the sole purpose of this medical device is monitoring, such as a glucose sensor, PLASOMA treatment is not contra-indicated but note that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment;

metal in the area 10 cm around pad-electrode area, e.g. metal sutures and implants;

Trial design

Design model

Parallel

Treatments tested in this trial

  • COLD ATMOSPHERIC PLASMA

    Device

    Cold Atmospheric plasma treatment in addition to standard wound care

Treatment groups

494 Participants
are divided into 2 treatment groups
Group A: Cold atmospheric PlasmaExperimental treatment 1 intervention
Group B: Standard Wound CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ulcer-free survival days

number of days within the follow-up period (until 26 weeks after the start of the treatment) where the participant is alive and has no ulcer on the same anatomical location of the same foot or limb

Time frame
26 weeks

Secondary outcomes

1

Quality of Life (QoL)

The quality of life will be determined using the questionnaires EQ-5D-5L (generic). EQ-5D-5L descriptive system is divided into five levels of perceived problems: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. LEVEL 1: no problem LEVEL 2: slight problems LEVEL 3: moderate problems LEVEL 4: severe problems LEVEL 5: unable to/extreme problems Best outcome is therefore a score of 1 in all categories (total score=5), and worst outcome is a score of 5 in all categories (total score=25).

Time frame
baseline, 13 weeks and 26 weeks
2

Wound Quality of Life (Wound-QoL)

The wound-QoL (wound-specific Quality of Life) will also be measured since complex wounds have a major impact on patients' well-being. The questionnaire is made of three subscales, body, psyche and everyday life. Answers to each item are coded with numbers (0='not at all' to 4='very much'). Minimal score is therefore 0 (no impairement) and maximal 17 (maximum impairement). The higher the outcome the worst the quality of life.

Time frame
baseline, 13 weeks, 26 weeks
3

Wound healing rate

is defined as the percentage of wounds that are healed

Time frame
26 weeks
4

time to wound healing

defined as the period measured in days between the start of the treatment period and confirmed wound healing as defined under primary endpoint

Time frame
26 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olaf Bakker

Lead sponsor

St. Antonius Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: