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NCT07418073
Transcutaneous CO₂ Therapy in Recurrent Hard-to-Heal Diabetic Foot Ulcers
NA trial testing transcutaneous application of gaseous CO2 on lower part of the body in Ulcer Foot in 30 participants. Completed in 30 August 2025.
20 March 2025
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2024 |
| Primary completion | 20 March 2025 |
| Estimated completion | 30 August 2025 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- transcutaneous application of gaseous CO2 on lower part of the body
Conditions studied
- Ulcer Foot — all drugs for Ulcer Foot →
Sponsor
University Medical Centre Ljubljana
Who can join
18 and older, any sex, with Ulcer Foot. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07418073
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Ulcer Foot
Currently open trials in the same condition.
- NCT07391319 — The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial · Phase 3 · recruiting
- NCT06124586 — Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS) · NA · recruiting
- NCT04210089 — Total Contact Soft Cast in Diabetic Foot Ulcers · NA · recruiting
Other University Medical Centre Ljubljana trials
Trials by the same sponsor.
- NCT07466472 — Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity · not yet recruiting
- NCT07446244 — Catheter Ablation of Advanced Forms of Atrial Fibrillation · NA · enrolling by invitation
- NCT07109076 — Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton · NA · recruiting
- NCT07354880 — Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease · Phase 4 · not yet recruiting
- NCT07496736 — Post-exposure Influenza Prophylaxis in a Hospital Setting · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07418073 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
- Last refreshed: 24 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07418073.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing