PLASOMA Ultimate Safety & Efficacy Study

NCT04828304 | Completed

• 1 other identifier: PULSE study
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy:

• FU1: 2 weeks after end treatment period
• FU2: 12 weeks after end treatment period
• FU3: 12 months after start treatment.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Burn Wound; Skin Graft; Infected Surgical Wound; Skin Flap

Outcome Measures

Primary Outcomes (3)

• Safety PLASOMA - device related SAEs

  device related SAEs

  12 months

• Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus

  Reduction in number of S. aureus colonies, using wound swab and quantitative analysis

  once at week 1 (wound swab directly before and after first PLASOMA treatment)

• Efficacy PLASOMA - wound surface area reduction

  Wound surface area reduction

  12 weeks

Secondary Outcomes (11)

• Safety PLASOMA - all AEs

  12 months

• Safety PLASOMA - wound appearance

  24 weeks

• Efficacy PLASOMA - Bacterial load reduction

  once at week 1 (wound swab directly before and after first PLASOMA treatment)

• Efficacy PLASOMA- wound healing

  12 weeks

• Efficacy PLASOMA - Quality of Life

  14 weeks

Study Arms (2)

control group

NO INTERVENTION

Standard of care

treatment group

EXPERIMENTAL

Standard of care + PLASOMA treatment

Device: PLASOMA

Interventions

PLASOMA DEVICE

Treatment with cold plasma device

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited to:
• diabetic ulcers (Wagner-Meggitt classification system/ University of Texas classification system: grades 1-3)
• venous ulcers
• pressure ulcers (international NPUAP/EPUAP classification system: categories/stages II-IV)
• burn wounds (second and third degree)
• skin grafts and flaps
• infected post-surgical ulcers. Standard wound care has not resulted in sufficient healing after at least two weeks (including first line care) (Ref 25, Ref 26).

You may not qualify if:

• INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 4.5 cm (\~16 cm2 wound surface area for circular wounds).
• INCL3: have a minimum age of 18 years old.
• INCL4: for home care treatments only: have a grounded wall socket available for connection of PLASOMA.
• EXCL1: the subject has one or more of the following contraindications for PLASOMA:
• the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry.
• any implanted active electronic device, such as a pacemaker, is present.
• an electronic medical device is attached to the body, including electronic life support equipment, hearing aids, glucose sensors and insulin pumps. If the sole purpose of the medical device is monitoring, the subject is not excluded, but it should be noted 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.
• a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode.
• a conductive connection from outside to inside the body at or near the heart is present, e.g. a catheter with electrolyte fluid.
• the subject has epilepsy
• the subject is pregnant
• the to-be-treated wound is located on the torso above the navel
• EXCL2: the subject has any known malignant wound degeneration.
• EXCL4: the subject is receiving or likely to receive advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - until FU1 for the to be-treated wound. Advanced wound dressings are not excluded.
• EXCL5: the subject participates in another study which is likely to compromise the outcome of the PULSE study or the feasibility of the subject fulfilling the PULSE study.

Sponsors & Collaborators

• Plasmacure: lead
• Diabetes Fonds: collaborator
• Pathology and Medical Microbiology: collaborator

Study Sites (6)

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Alrijne Ziekenhuis

Leiderdorp, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Location

Expertisecentrum Wondzorg (EcW)

Oosterhout, Netherlands

Location

Maxima Medisch Centrum (MMC)

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Burns; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koen Lim

  Plasmacure

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 2, 2021
• Study Start: May 26, 2021
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

NL (6)