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Clinical Trial Summary

The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on peripheral diabetic neuropathy. 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 diabetic peripheral neuropathy and improvement in circulation could have positive effect also on peripheral neuropathy. In order to evaluate the effect of transcutaneous application of CO2 on peripheral neuropathy in diabetic patients the investigators designed a randomised double blind clinical trial.

Clinical Trial Description

Transcutaneous application of gaseous CO2 showed to be a successful adjuvant therapy in treatment of chronic wounds in diabetic patients (PMID: 32633896). During that research patients reported improvement in peripheral sensation after treatment. Therefore, in order to investigate the influence of transcutaneous application of gaseous CO2 in peripheral diabetic neuropathy the investigators designed a randomised double blind research. 60 diabetic patients with peripheral diabetic neuropathy will be randomised in study and control group. Study group will receive 20 treatments with CO2 (each workday for 4 weeks). Lower part of the body is inserted into therapeutic wrap that is filled with 99.9% CO2 gas for 45 minutes. The same approach will be used in control group but in their case the therapeutic wrap will be filled with air. In both groups investigator will evaluate vibration sensation, monofilament test and temperature of the big toe before first and after 4 weeks of treatment. Patients as well as investigator (doctor) will be blind for the group belonging of the patients. The medical nurse performing all the therapies will randomise the patients using random number generator into study and control group. The nurse will be the only one knowing group belonging of the patients until the obtained results from both groups will be compared. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04561609
Study type Interventional
Source University Medical Centre Ljubljana
Contact Helena Ban Frangez, PhD, MD
Phone +38641336441
Status Recruiting
Phase N/A
Start date May 2, 2020
Completion date December 30, 2021

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