diabetic foot. Type 2 diabetes mellitus with skin complications
Conditions
Interventions
Intervention 1: Intervention group: Receive a topical form of melatonin (Razak Pharmaceutical Company) with standard regime(Blood sugar control, regular wound washing, pressure reduction on the wound,
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients equal and more18 years old Grade 1 or 2 diabetic foot ulcers based on wagner Patients with HgbA1c 0.4 or Color Doppler Ultrasound with no result of severe vascular involvement
Exclusion criteria
Exclusion criteria: Need to have injectable antibiotics Allergy to topical melatonin product Patients with uncontrolled epilepsy Pregnancy and lactation Any skin disorder leads to ulcer Causes of wounds other than diabetes such as trauma Wounds happened in less than 2 weeks Patients treated with chemotherapy or radiotherapy Use of drugs that interfere with wound healing, such as: corticosteroids at least the equivalent dose of 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab Patients with renal disease at stage 5(GFR<15 ml/min) or on dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area. Timepoint: At the baseline (before intervention) and at the fourth week , Eighth week of intervention. Method of measurement: Using photos and area measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality. Timepoint: Start of study, eighth week. Method of measurement: sleep questionnaire(Pittsburgh Sleep Quality Index).;Life quality. Timepoint: Start of study, eighth week. Method of measurement: Diabetic Foot Ulcer Scale(DFS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAyda Esmaeili
Oroumia University of Medical Sciences
Outcome results
None listed