CompletedNot Applicable

Transcutaneous Application of Gaseous CO2

Croatia, Slovenia120 participantsStarted 2023-05-15

Plain-language summary

The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on chronic wound healing. Transcutaneous application of CO2 is known to have immediate effect on vasodilatation and elevates oxygen release from Hb via the Bohr effect. After repetition of the therapies neoangiogenesis is induced. Impairment of microcirculation is one of the causes of impared wound healing and improvement in circulation could have positive effect on wound healing, reduction of the wound area and granulation of the wound bed (Falanga score).

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * confirmed diagnosis of DM Type 1 or Type 2, * confirmed diagnosis of a non-healing DFU without clinical signs of infection, * being able to provide informed consent for the participation, and Exclusion Criteria: * patients with severe comorbidities: deep vein thrombosis, chronic kidney diseases grade III and IV, chronic heart diseases NYHA (New York Heart Association) III and IV, patients with known malignant diseases, patients with progressive infection, signs of systemic infection with elevated inflammatory markers or osteomyelitis

What they're measuring

Ratio of completely healed wounds

Timeframe: after 4 weeks of therapy with CO2 or standard of care

Trial details

NCT IDNCT04561609

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) trials