N/A
Completed N=20
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
Source: ClinicalTrials.gov NCT02677779 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Bacterial Load — -99.9; -50.0 Percent change from baseline
Summary
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Load |
-99.9; -50.0 | — |
| SECONDARY Pain: Scores of Brief Pain Inventory |
0; 1.0 | — |
| SECONDARY Fibrin: Percent of Ulcer Area Covered by Fibrin |
-83.1; -42.9 | — |
| SECONDARY Granulation: Percent of Ulcer Area Covered by Granulation. |
307.7; 230.4 | — |
| SECONDARY Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis |
2; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes
- Infected foot ulcer (with clinical signs of infection)
- Ulcer area between 0.5 and 150 cm2
- More than 50% of ulcer area covered by fibrin and/or necrosis
- Texas score <3
Exclusion Criteria
- Need for revascularization
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT02677779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.