Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing (PLASFRI-CUV)
Venous Leg Ulcer
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Cold atmospheric plasma, venous ulcer, wound healing
Eligibility Criteria
Inclusion Criteria: Be of legal age (18 years). Signed informed consent. Presenting at least one venous ulcer larger than 1 cm2 that has not healed in the last 3 weeks from its appearance. Absence of surgical indication for ulcer coverage by skin graft. Exclusion Criteria: Uncontrolled diabetes mellitus (HbA1c > 8%). If during the trial the patient suffers a decompensation of diabetes, it will be considered an adverse event. Patient allergic to silver or any other material that will be used during the cure of the ulcer under study. Concomitant treatment with vacuum-assisted closure (VAC) therapy. Use of topical antibiotic therapy. The minimum washing time should be 48 hours. Presence of critical limb ischemia defined as an ankle-brachial index (ABI) below 0.5 or a transcutaneous O2 pressure (TcPO2) below 15 mmHg. Treatment with corticosteroids in the 14 days prior to the study or with other immunosuppressants. Presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome, systemic lupus erythematosus, systemic sclerosis, or psoriasis). Pregnancy or lactation. Advanced or metastatic stage cancer. Deficiency states. Dementia. Post radiation wounds. Sepsis.
Sites / Locations
- Clinica Universidad de NavarraRecruiting
- Clinica Universidad de NavarraRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cold Athmospheric Plasma Jet+Alginate patch
Alginate patch
Leg Venous Ulcers will be treated in all patients belonging to the experimental arm using the PlasmAction Med cold plasma generator at atmospheric air pressure and alginate (Melgisorb Ag®) will be used after the plasma has been applied.
For patients included in the control arm, alginate (Melgisorb Ag®) will be used as a cure for ulcers, size 10 X 10 cm and 5x5 (3 units), whose replacements will also be carried out twice a week.