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Transcutaneous Application of Gaseous CO2

NCT ID: NCT04561609

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-02

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peripheral Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The use of transcutaneous application of gaseous CO2 for treatment of diabetic peripheral neuropathy. A double blind clinical trial. Control group receives placebo treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Patients will not know to which group they belong. They will all receive treatment (study group with CO2, control group with air), the nurse who will prepare the gas for treatment will know the group belonging for the patient. The investigator, who will evaluate neuropathy before and after treatment will not know the group belonging of the patient. At the end, the person evaluating the results will compare results from 2 groups, not knowing which one was study and which control.

Study Groups

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CO2 treated

Patients receiving treatment with transcutaneous application of gaseous CO2 on lower limbs

Group Type ACTIVE_COMPARATOR

Transcutaneous CO2 application

Intervention Type OTHER

Patients lie on examination tables. Lower extremities of the patients are isolated in a therapeutic wrap (single use, low-density, made from biocompatible polyethylene), sealed at the waist. After this, air is first pumped out of the therapeutic wrap, then the wrap was filled with 99.9% CO2 gas. The therapy lasts for 45 minutes.

Each patient from the study group will receive CO2 therapies - four weeks (meaning 20 CO2 therapies that were performed on workdays only).

control

Patients receiving placebo treatment with air on lower limbs

Group Type PLACEBO_COMPARATOR

Placebo treatment

Intervention Type OTHER

Each patient from control group will have therapeutic wrap filled with air instead of CO2. Patients from control group will also receive 20 therapies (4 weeks on workdays only), that will also last 45 minutes.

Interventions

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Transcutaneous CO2 application

Patients lie on examination tables. Lower extremities of the patients are isolated in a therapeutic wrap (single use, low-density, made from biocompatible polyethylene), sealed at the waist. After this, air is first pumped out of the therapeutic wrap, then the wrap was filled with 99.9% CO2 gas. The therapy lasts for 45 minutes.

Each patient from the study group will receive CO2 therapies - four weeks (meaning 20 CO2 therapies that were performed on workdays only).

Intervention Type OTHER

Placebo treatment

Each patient from control group will have therapeutic wrap filled with air instead of CO2. Patients from control group will also receive 20 therapies (4 weeks on workdays only), that will also last 45 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with diabetes and peripheral symmetrical diabetic neuropathy
* with unilateral chronic wound, without previous amputations
* with scores above 3 on the Michigan Neuropathy Scoring Instrument

Exclusion Criteria

* diabetic patients with asymmetrical peripheral neuropathy
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Helena Ban Frangez

assistant professor MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Igor Frangez, PhD, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

UCMLjubljana

Locations

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UMCLjubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Helena Ban Frangez, PhD, MD

Role: CONTACT

[email protected]
+38641336441

Facility Contacts

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Helena Ban Frangez, PhD, MD

Role: primary

[email protected]
+38641336441

Igor Frangez, PhD, MD, DDS

Role: backup

[email protected]
+386682112

References

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Smith AG, Ramachandran P, Tripp S, Singleton JR. Epidermal nerve innervation in impaired glucose tolerance and diabetes-associated neuropathy. Neurology. 2001 Nov 13;57(9):1701-4. doi: 10.1212/wnl.57.9.1701.

Reference Type BACKGROUND
PMID: 11706115 (View on PubMed)

Sakai Y, Miwa M, Oe K, Ueha T, Koh A, Niikura T, Iwakura T, Lee SY, Tanaka M, Kurosaka M. A novel system for transcutaneous application of carbon dioxide causing an "artificial Bohr effect" in the human body. PLoS One. 2011;6(9):e24137. doi: 10.1371/journal.pone.0024137. Epub 2011 Sep 8.

Reference Type BACKGROUND
PMID: 21931656 (View on PubMed)

Macura M, Ban Frangez H, Cankar K, Finzgar M, Frangez I. The effect of transcutaneous application of gaseous CO2 on diabetic chronic wound healing-A double-blind randomized clinical trial. Int Wound J. 2020 Dec;17(6):1607-1614. doi: 10.1111/iwj.13436. Epub 2020 Jul 7.

Reference Type BACKGROUND
PMID: 32633896 (View on PubMed)

Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

Reference Type BACKGROUND
PMID: 20876709 (View on PubMed)

Other Identifiers

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UMCLjubljana CO2 application

Identifier Type: -

Identifier Source: org_study_id