Diabetic foot ulcer. Type 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients over the age of 18 with a history of type 2 diabetes and hemoglobin A1C less than 10% Adequate literacy to fill the consent form, comprehension study Diabetic foot ulcer
Exclusion criteria
Exclusion criteria: Gangrene of the foot Osteomyelitis Severe sepsis History of alcohol consumption or substance abuse History of chronic diseases such as cancers or congestive heart failure, ESRD, liver failure Concomitant use of drugs that can adversely affect the wound healing process: glucocorticoids, immunosuppressive drugs, cytotoxic drugs Failure to sign a written consent Pregnant and lactating women Patients taking atrovastatin Patients with a history of steroid, cytotoxic or immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of wound closures 1 to 4 per week. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0).;Re-epithelialization. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0). | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of the pain. Timepoint: Examination from 7 days before prescribing the drug in terms of entry criteria, treatment (day zero to 4 weeks), and phase follow-up (2 and 3 months). Method of measurement: Basal Visual analogue Scale (VAS) criterion.;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: Based on Morisky medication adherence scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Yazd University of Medical Sciences