Comparing the high dose and conventional regimen of vitamin D effect on paraclinical factors affecting the healing of diabetic foot ulcer
Design
An open-label, randomized clinical trial study with parallel groups and phases 3 on 60 patients. Randomization will be done according to block randomization method using Random allocation software.
Settings and conduct
In this open-label clinical trial study, 60 patients over 18 years of age with grade 3 and 4 diabetic foot ulcers admitted to Urmia Imam Khomeini Hospital will be included. Patients will be randomly treated with the conventional (Vitamin D 50,000 units weekly for up to three weeks) and high dose (injection of 300,000 muscle units at the beginning of hospitalization) of vitamin D regimens.
Participants/Inclusion and exclusion criteria
In this study, 60 patients with inclusion criteria including patients over 18 years of age, suffering from 3 and 4 degree of diabetic foot ulcers according to Wegener criteria will be included. The main exclusion criteria include taking vitamin D supplements during the last month, patients with severe renal failure GFR<30 ml/min and pregnancy and breastfeeding.
Intervention groups
In the first group, patients will be treated with vitamin D 50,000 units weekly for three weeks (conventional regimen). For patients in the second group, an ampoule of 300,000 units of vitamin D will be injected intramuscularly at the beginning of hospitalization (high dose regimen).
Comparing the high dose and conventional regimen of vitamin D effect on paraclinical factors affecting the healing of diabetic foot ulcer
Public title
Investigating the effect of vitamin D in the treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with vitamin D levels between 10-30 ng/dL
Age over 18 years
Diabetic foot ulcer grade 3 and 4 according to Wegener criteria
Plasma calcium below 10
Platelet count above 100,000
Exclusion criteria:
Allergy to vitamin D products
Known diseases associated with hypercalcemia
Pregnancy and breastfeeding
Patients treated with chemotherapy or radiotherapy drugs
Taking drugs that interfere with wound healing, such as: corticosteroids, a minimum dose equivalent to 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab
Patients with severe renal failure, GFR<30 ml/min
Taking vitamin D supplements during the last month
Received injectable antibiotics for diabetic foot ulcer during the last month before hospitalization
Stenosis and severe clogging of vessels of the lower limbs based on vascular ultrasound
Chronic alcohol consumption of more than 250 cc daily
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be implemented. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups.Therefore, patients will be individually will be assigned into one of the two groups based on the computer-generated number list.Thus, the randomization process will continue until the final sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences
Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy
Primary outcomes
1
Description
Erythrocyte Sedimentation (ESR)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
2
Description
C-reactive protein (CRP)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
3
Description
Fasting blood sugar (FBS)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
4
Description
Glomerular filtration rate (GFR)
Timepoint
Before and three weeks after the intervention
Method of measurement
Based on the formula
5
Description
Creatinine
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
6
Description
Alanine transaminase (ALT)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
7
Description
Aspartate transferase (AST)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
8
Description
Alkaline phosphatase (ALP)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
Secondary outcomes
1
Description
White blood count (WBC)
Timepoint
Before and three weeks after the intervention
Method of measurement
Neobar slide (hemocytometer)
2
Description
Mean platelet volume (MPV)
Timepoint
Before and three weeks after the intervention
Method of measurement
Neobar slide (hemocytometer)
3
Description
Platelet count
Timepoint
Before and three weeks after the intervention
Method of measurement
Neobar slide (hemocytometer)
4
Description
Triglyceride (TG)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
5
Description
Cholesterol
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
6
Description
High-density lipoprotein (HDL)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
7
Description
Low-density lipoprotein (LDL)
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
8
Description
Calcium
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
9
Description
Ferritin
Timepoint
Before and three weeks after the intervention
Method of measurement
Biochemistry test
Intervention groups
1
Description
Intervention group: In the first group, patients will be treated with vitamin D 50,000 units orally weekly for three weeks (conventional regimen).Tablets will be provided by Dana Pharmaceutical Company.
Category
Treatment - Other
2
Description
For patients in the second group, 300,000 units of vitamin D ampoule will be injected intramuscularly at the beginning of hospitalization (high dose regimen). Ampoules will be provided by Dana Pharmaceutical Company.