topical efficacy of melatonin on diabetic foot ulcer healing
Design
Clinical trial, with parallel groups, double-blind, randomized, on 50 patients. Randomization outcome will be done in a block of 4 and through using excel software.
Settings and conduct
This study is going to be carried out at the Endocrinology clinics of Imam Khomeini affiliated with the Urmia University of Medical Sciences. Patients will be divided into two groups of 25 subjects. Each patient will receive topical gel of melatonin or placebo for 8 weeks. During the study, patients will receive standard care and treatment regimens for diabetic foot in both groups. The area and number of wounds are measured before the start of treatment and after 4 weeks and then at the end of 2 months. Researcher and patients will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Grade 1 or 2 diabetic foot ulcers based on wagner, Patients with HgbA1c <=10% , Obtain informed consent Patients
Wound size more than one cm2 , Patients with ankle brachial index> 0.4 or Color Doppler Ultrasound with no result of severe lower artery involvement.
Exclusion criteria:
Need for injectable antibiotics, Allergy to topical melatonin product, Patients with uncontrolled epilepsy , Pregnancy and lactation
Underlying skin disease leads to scarring Causes of wounds other than diabetes include 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
Intervention groups
Interventional group: receives topical gel of melatonin at night. Control group: receives topical gel of placebo at night
Main outcome variables
wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200220046560N1
Registration date:2021-04-09, 1400/01/20
Registration timing:registered_while_recruiting
Last update:2021-04-09, 1400/01/20
Update count:1
Registration date
2021-04-09, 1400/01/20
Registrant information
Name
Ayda Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 0046
Email address
ph.a.esmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-01, 1400/01/12
Expected recruitment end date
2022-03-31, 1401/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The efficacy of topical Melatonin on healing of diabetic foot ulcers in a double blind placebo-controlled clinical trial
Public title
Evaluation of The efficacy of topical Melatonin on healing of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used in this study. The size of all blocks is equal and 5 blocks of 10 including 25 patients in the intervention group and 25 patients in the control group will be used. To determine the random sequence of drug and placebo allocation within each block, the site https://studyrandomizer.com/ is used and the sequences (sequence within block) are received in the form of an Excel file from the site. The output file will be assigned to each person a four-part code consisting of a letter and three digits separated by commas. In order to conceal random allocation, the method of opaque sealed envelopes with random sequence will be used. Fifty envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) will be prepared and each of the random sequences created on one card will be recorded and the cards will be placed in the envelopes respectively. In order to maintain a random sequence, the envelopes will be numbered in the same way on the outer surface.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and researcher do not know about type of drug that receive ( melatonin or placebo) and are blinded. Placebo are prepared in same shape and color of melatonin topical Gel. Drug and placebo are coded in A and B groups with block randomization method. Then they are given to the researcher and patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Urmia University of Medical Sciences
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, treatment with oral antibiotics if needed) and the instruction to use overnight rub into the wound for 8 weeks and the ultimate goal is to use one milligram of melatonin (0.2%) per square centimeter of wound.
Category
Treatment - Drugs
2
Description
Control group: Receive a topical form of placebo (Distilled water, carbomer, TEA) (school of pharmacy)with standard regime and the instruction to use overnight rub into the wound for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک درمان دیابت و زخم پای دیابتی وابسته به دانشگاه علوم پزشکی ارومیه