Diabetic foot ulcers
Conditions
Interventions
Dermofural® 0.15% ointment, once daily for 7 days by topical route.
First cleaning the lesion will be performed with saline solution. Subsequent to drying, apply topical antimicrobial and placing band
Anti-Bacterial Agents
Anti-Infective Agents
Sponsors
Chemical Bioactive Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the established diagnostic criteria. 2. Patients older than 18 years. 3. Patients express voluntary by signing the informed consent to participate in research and completing the set exams.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, postpartum or breastfeeding. 2. History of allergy or hypersensitivity to Dermofural or any of its components. 3. Patients suffering or concern clinically determined by the physician either decompensated chronic illness. 4. Patients being treated with immunotherapy or other cancer treatment or who have received in the last three months prior to this study. 5. Patients with serious psychiatric disorders or mental disability that prevents him expressing their willingness to participate in the study or evaluation difficult. 6. Patients who are or have been recently involved (1 month) in another study. 7. Patients with other active infections requiring the use of antibacterial agents during the study. 8. Patients who have received systemic antibacterial therapy in the 72 hours before the start of the study. 9. Patients with more than one diabetic foot ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (assessing the severity of infection according to the Infectious Diseases Society of America -IDSA- Criteria: uninfected, mild, moderate and severe). Measuring time: daily, during 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Microbiological response (presence or absence of bacterial growth in the UPD). Measuring time: basal, end of treatment 2. Safety (identification of adverse events occurring during the application of the test product). Measuring time: daily, during 7 days.. Occurrence (yes/no), Description (EA presented is reported using an accurate medical terminology), Duration (date difference between the beginning and the end of the event), Intensity (mild, moderate or severe), Seriousness (serious/serious or not serious/not serious), Attitude toward the drug (unchanged or permanent discontinuation), Results (recovered, improved persists, worsens, death), Causation (likely/certain, probable, possible, unlikely, unrelated or not evaluable/unclassifiable), Local events (yes/no), Systemic events (yes/no). -Biochemical parameters (Hemoglobin g/L, total leukocyte count cells/L, neutrophils %, lymphocytes %, monocytes %, eosinophils %, basophils %, platelet count cells/L, erythro mm/h, creatinine mmol/L, TGO U/L, TGP U/L). Measuring time: baseline, end of treatment. (Glucose mmol/L). Measuring time: daily, for 7 days. | — |
Countries
Cuba
Contacts
Public ContactYenni González Lugo
Chemical Bioactive Center
Outcome results
None listed