Diabetic foot ulcer with mild infection
Conditions
Interventions
Group 1 (study) Dermofural®, a daily application of the ointment, for 7 days, topical. First, the lesion will be cleaned with physiological saline at room temperature. After drying, the product will b
Anti-Bacterial Agents
Anti-Infective Agents
Placebos
Sponsors
Chemical Bioactive Center
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with a microbiological and clinical diagnosis of superficial UPD with mild infection, newly diagnosed or previously treated. 2. Grade 1 UPD according to Wagner's classification. 3. Neuropathic UPD. 4. Time elapsed since the last treatment indicated for UPD = 4 weeks. 5. Patients = 19 years. 6. Patients who express written voluntariness by signing the informed consent to participate in the research.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, postpartum or breastfeeding. 2. Patients with a history of allergy or hypersensitivity to Dermofural®/placebo or any of its components. 3. Patients with decompensated chronic diseases including, but not limited to: diabetes mellitus, venous insufficiency, arterial hypertension, bronchial asthma, interstitial fibrosis, chronic renal failure, ischemic heart disease, symptomatic congestive heart failure, aortic stenosis, endocarditis, unstable angina pectoris, cardiac arrhythmia. 4. Patients who are being treated with immunotherapy or other oncological treatment or who have received it in the last three months prior to this study. 5. Patients with autoimmune diseases. 6. Patients with a history of psychiatric illness or mental incapacity that prevents them from expressing their willingness to participate in the study or hinders their evaluation and treatment. 7. Patients who have recently participated (1 month) or are participating in another clinical trial at the time of selection. 8. Patients with active systemic or local infections that require the use of other antibacterial agents. 9. Patients who have received systemic antibacterial treatment in the 72 hours prior to the time of selection. 10. Patients who fail to comply with at least one of the daily treatments in the pre-inclusion period. When a patient meets the 3rd exclusion criterion, they may be scheduled for a consultation, within a period of time agreed between the doctor and the patient, to re-evaluate their response to the treatment of the chronic disease in question.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global response (combination of clinical and microbiological response). It will be evaluated in the categories “Satisfactory” and “Unsatisfactory” where: - Satisfactory: when 48 hours after the last application of the assigned treatment, the response clinical lesion is in the non-infected category (no presence of any signs and symptoms clinical: (inflammation, induration, tenderness, edema, redness, erythema, pain, local heat, hyperesthesia and purulent secretion) and present microbiological response (absence of bacterial growthm in DFU or healed ulcer). Unsatisfactory: when 48 hours after the last application of the assigned treatment, the response clinical presentation of the lesion is in the categories “mild”, “moderate” or “severe” with or without growth bacterial in the DFU, or present clinical response in the “uninfected” category with growth bacterial in the UPD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: before starting treatment with Dermofural®/placebo and after finishing it. Glycosylated hemoglobin %. Measuring time: before starting treatment with Dermofural®/placebo. | — |
Countries
Cuba
Contacts
Public ContactYenni González Lugo
Chemical Bioactive Center
Outcome results
None listed