Evaluation of The efficacy of topical Melatonin on healing of diabetic foot

Phase 2

• Conditions: diabetic foot.; Type 2 diabetes mellitus with skin complications; E11.62

• Registration Number: IRCT20200220046560N1
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients equal and more18 years old
Grade 1 or 2 diabetic foot ulcers based on wagner
Patients with HgbA1c<=10%
Obtain informed consent
The size of the wound is more than one cm2
Index affected by ankle> 0.4 or Color Doppler Ultrasound with no result of severe vascular involvement

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).