Ulcer FootNCT07418073
Transcutaneous CO₂ Therapy in Recurrent Hard-to-Heal Diabetic Foot Ulcers
A study testing transcutaneous application of gaseous CO2 on lower part of the body in people with Ulcer Foot, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Recurrent and hard-to-heal diabetic foot ulcers (DFUs) represent a clinically challenging subgroup with delayed closure and frequent non-response to standard of care (SOC). Impaired local perfusion and superficial tissue hypoxia, commonly attributed to microcirculatory dysfunction, are proposed contributors to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Foot
- What is being tested?
- transcutaneous application of gaseous CO2 on lower part of the body
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 1 or 2
- recurrent hard to heal DFU
Who cannot join
- KOPD stage IV
- CKD stage IV
- malignant diseases
- pregnancy
- infected ulcer at baseline
- inability to comply with visits
Trial locations and contacts
1 site in 1 country.
About this study
Recurrent and hard-to-heal diabetic foot ulcers (DFUs) represent a clinically challenging subgroup with delayed closure and frequent non-response to standard of care (SOC). Impaired local perfusion and superficial tissue hypoxia, commonly attributed to microcirculatory dysfunction, are proposed contributors to impaired wound-bed progression and prolonged healing trajectories in diabetes. Transcutaneous gaseous carbon dioxide (CO₂) therapy is a non-invasive adjunct intervention with a mechanistic rationale to modulate local microcirculation and tissue oxygenation; however, controlled clinical evidence in recurrent, hard-to-heal DFUs remains limited. This prospective, randomized, controlled, open-label, parallel-group clinical investigation compares transcutaneous CO₂ therapy plus SOC versus SOC alone over 4 weeks. The primary objective is to determine whether the proportion of completely healed DFUs at Week 4 differs between groups under a predefined healing confirmation procedure. Key secondary objectives include quantifying changes in superficial tissue oxygenation (StO₂) using hyperspectral imaging and assessing pain intensity (NPRS). Supportive outcomes include ulcer area reduction metrics and wound-bed appearance in unhealed.
- Conditions
- Ulcer Foot
- Being tested
- transcutaneous application of gaseous CO2 on lower part of the body
- Keywords
- Diabetic foot ulcer, CO2 therapy, microcirculation
- Medical subject headings
- Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous application of gaseous CO2 on lower part of the bodyOther
Participants in the intervention group received SOC alongside 20 sessions of CO₂ therapy. These 50-minute sessions were administered once daily on weekdays (Monday-Friday) over a 4-week period. CO₂ therapies were performed using the medical device. The participant's lower body was sealed in a single-use, biocompatible, medical-grade wrap. The wrap was filled with medical-grade CO₂ to a 99.9% concentration for a 50-minute session. After 50 minutes, CO₂ was pumped out and the wrap removed.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care + CO2 therapy | Experimental | Standard of care (3 times weekly) + transcutaneous gaseous CO2 therapy 20 times (every weekday for 50 minutes) Receives: Other: transcutaneous application of gaseous CO2 on lower part of the body |
| Standard of care | No intervention | Standard of care (3 times weekly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete ulcer healing
full epitelization without exudate confirmed at 2 consecutive exams
Measured: 4 weeks
Secondary outcomes (2)
change in StO2
StO₂ (%) will be measured using Hyperspectral Imaging (by TIVITA HSI device) at baseline and weeks 1, 2, 3, and 4. The outcome is change from baseline in StO₂ (%). Higher values indicate better tissue oxygenation/perfusion.
Measured: 4 weeks
change in pain intensity (NPRS)
Change from baseline in pain intensity assessed by the Numeric Pain Rating Scale (NPRS)Outcome Measure Description: Pain intensity will be self-reported using the Numeric Pain Rating Scale (NPRS), an 11-point scale from 0 = no pain to 10 = worst imaginable pain. The outcome is change from baseline in NPRS score at week 4.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Sep 2024
- Primary completion20 Mar 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcer FootStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Frangez, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418073
- Sponsor's protocol ID
- NM-DVS-CO2
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finzgar M, Melik Z, Cankar K. Effect of transcutaneous application of gaseous carbon dioxide on cutaneous microcirculation. Clin Hemorheol Microcirc. 2015;60(4):423-35. doi: 10.3233/CH-141898.
PubMed 25261433Macura 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.
PubMed 32633896
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous CO₂ Therapy in Recurrent Hard-to-Heal Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07418073
- Acronym / sponsor ID
- NM-DVS-CO2
- Conditions
- Ulcer Foot
- Keywords
- Diabetic foot ulcer, CO2 therapy, microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent and hard-to-heal diabetic foot ulcers (DFUs) represent a clinically challenging subgroup with delayed closure and frequent non-response to standard of care (SOC). Impaired local perfusion and superficial tissue hypoxia, commonly attributed to microcirculatory dysfunction, are proposed contributors to impaired wound-bed progression and prolonged healing trajectories in diabetes. Transcutaneous gaseous carbon dioxide (CO₂) therapy is a non-invasive adjunct intervention with a mechanistic rationale to modulate local microcirculation and tissue oxygenation; however, controlled clinical evidence in recurrent, hard-to-heal DFUs remains limited. This prospective, randomized, controlled, open-label, parallel-group clinical investigation compares transcutaneous CO₂ therapy plus SOC versus SOC alone over 4 weeks. The primary objective is to determine whether the proportion of completely healed DFUs at Week 4 differs between groups under a predefined healing confirmation procedure. Key secondary objectives include quantifying changes in superficial tissue oxygenation (StO₂) using hyperspectral imaging and assessing pain intensity (NPRS). Supportive outcomes include ulcer area reduction metrics and wound-bed appearance in unhealed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care + CO2 therapy | Experimental | Other: transcutaneous application of gaseous CO2 on lower part of the bodyStandard of care (3 times weekly) + transcutaneous gaseous CO2 therapy 20 times (every weekday for 50 minutes) |
| Standard of care | No intervention | –Standard of care (3 times weekly) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diabetes mellitus type 1 or 2
- recurrent hard to heal DFU
Key exclusion criteria (6 listed)
- KOPD stage IV
- CKD stage IV
- malignant diseases
- pregnancy
- infected ulcer at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous application of gaseous CO2 on lower part of the bodyParticipants in the intervention group received SOC alongside 20 sessions of CO₂ therapy. These 50-minute sessions were administered once daily on weekdays (Monday-Friday) over a 4-week period. CO₂ therapies were performed using the medical device. The participant's lower body was sealed in a single-use, biocompatible, medical-grade wrap. The wrap was filled with medical-grade CO₂ to a 99.9% concentration for a 50-minute session. After 50 minutes, CO₂ was pumped out and the wrap removed. | Other | Standard of care + CO2 therapy |
Primary outcome
complete ulcer healing
Time frame: 4 weeks
full epitelization without exudate confirmed at 2 consecutive exams
2 secondary outcomes
change in StO2
Time frame: 4 weeks
change in pain intensity (NPRS)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 25261433Finzgar M, Melik Z, Cankar K. Effect of transcutaneous application of gaseous carbon dioxide on cutaneous microcirculation. Clin Hemorheol Microcirc. 2015;60(4):423-35. doi: 10.3233/CH-141898.
- Background: PubMed 32633896Macura 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.
- Individual participant dataSharing planned: No
Related trials for Ulcer Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous application of gaseous CO2 on lower part of the body in people with Ulcer Foot, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete ulcer healing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418073, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.