NCT07418073

Transcutaneous CO₂ Therapy in Recurrent Hard-to-Heal Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
OTHER	transcutaneous application of gaseous CO2 on lower part of the body	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-20
• Completion: 2025-08-30
• First posted: 2026-02-18
• Last updated: 2026-02-24

Locations

1 site across 1 country: Slovenia