- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04561609
Transcutaneous Application of Gaseous CO2
The Effect of Transcutaneous Application of Gaseous CO2 on Diabetic Symmetrical Peripheral Neuropathy - A Double Blind Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helena Ban Frangez, PhD, MD
- Phone Number: +38641336441
- Email: helena.ban.frangez@gmail.com
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Recruiting
- UMCLjubljana
-
Contact:
- Helena Ban Frangez, PhD, MD
- Phone Number: +38641336441
- Email: helena.ban.frangez@gmail.com
-
Contact:
- Igor Frangez, PhD, MD, DDS
- Phone Number: +386682112
- Email: ifrangez@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CO2 treated
Patients receiving treatment with transcutaneous application of gaseous CO2 on lower limbs
|
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). |
Placebo Comparator: control
Patients receiving placebo treatment with air on lower limbs
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vibration sensation
Time Frame: before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
|
Vibration sensation is performed using a 128 Hz tuning fork on 5 standard points on each foot (on the skin above a bony prominence the first metatarsophalangeal joint (MPT), the apex of the hallux, malleolus, diaphysis of tibia and tibia tuberosity).
Results are presented as number of points (out of 10) with no vibration sensation.
|
before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
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Change in Monofilament test
Time Frame: before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
|
Monofilament testing is performed using Semmes Weinstein Monofilament (SWM) 10 g on 8 standard points on each foot (on the plantar surface of the great toe, third and fifth toe, on the plantar surface of the first, third and fifth metatarsal head, on the plantar arch and on the plantar surface of the calcaneus).
Results are presented as number of points (out of 16) with no sensation.
|
before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skin temperature
Time Frame: before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
|
the temperature measured with infrared thermometer on the plantar of the big toes using infrared thermometer.
Temperature measurement was standardized - before treatment (in order to exclude increased temperature during the CO2 therapy due to vasodilatation).
Patients are left to lie on the examination table, barefoot for 20 minutes to adjust to the room temperature.
|
before first therapy with CO2 or placebo and after 4 weeks of therapy with CO2 or placebo
|
Collaborators and Investigators
Investigators
- Principal Investigator: Igor Frangez, PhD, MD, DDS, UCMLjubljana
Publications and helpful links
General Publications
- 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. Erratum In: Diabetes Care. 2010 Dec;33(12):2725.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCLjubljana CO2 application
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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