Ulcer Foot
Conditions
Keywords
Diabetic foot ulcer, CO2 therapy, microcirculation
Brief 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.
Interventions
OTHERtranscutaneous 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.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetes mellitus type 1 or 2 * recurrent hard to heal DFU
Exclusion criteria
* KOPD stage IV * CKD stage IV * malignant diseases * pregnancy * infected ulcer at baseline * inability to comply with visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete ulcer healing | 4 weeks | full epitelization without exudate confirmed at 2 consecutive exams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in StO2 | 4 weeks | 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. |
| change in pain intensity (NPRS) | 4 weeks | 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. |
Countries
Slovenia
Outcome results
None listed