Diabetic foot ulcer. Type 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Intervention 1: Intervention group: Patients will use 2.5% sildenafil emulgel twice daily for 4 weeks in addition to standard treatments including oral clindamycin and ciprofloxacin. Sildenafil emulg
Sponsors
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years old with type 1 or type 2 diabetes and hemoglobin A1C less than 10% Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion criteria
Exclusion criteria: Gangren Foot Osteomyelitis Severe sepsis A history of alcohol or substance abuse History of chronic diseases such as cancer or congestive heart failure, ESRD, liver failure Concomitant use of drugs that may have a negative impact on the wound healing process: Glucocorticoids, immunosuppressive drugs, cytotoxic drugs Not taking the medicine correctly Failure to sign written consent Pregnant and lactating women Complications with topical medication use Failure to attend follow up sessions while receiving medication Patients with a history of steroid, cytotoxic or immunosuppressive drugs Patients taking oral atorvastatin
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The severity of the pain. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Recovery percentage. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: Based on Morisky medication adherence scale.;Quality of Life. Timepoint: At the beginning and end of the study. Method of measurement: Based on 15 DQOL questionnaire. | — |
Primary
| Measure | Time frame |
|---|---|
| The length of the overall recovery period. Timepoint: daily. Method of measurement: REEDA score (3-0).;Inflation. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Redness. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Decreased secretions. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Saghafi
Yazd University of Medical Sciences
Outcome results
None listed