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N/A Completed N=20 Randomized Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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