Assessment of the N-Acetyl cysteine effect on therapeutic outcome of diabetic foot ulcers
Design
An open-label, randomized clinical trial study with parallel groups and phases 3 on 50 patients.Randomization will be done according to block randomization method using Random allocation software.
Settings and conduct
This open-label, randomized clinical trial study will be conducted on 50 patients of grades 3 and 4 of diabetic foot ulcers in Urmia Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
In this study, 50 patients over 18 years with grades 3 and 4 of diabetic foot ulcers based on Wegener criteria will be included. The main exclusion criteria include allergy to N-acetyl cysteine and sulfur products, Other causes of ulcers except diabetes include trauma and etc., taking drugs such as: corticosteroids at a minimum dose equivalent to 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab, and hospitalized patients for a diabetic foot ulcer in the last one month and receiving injection antibiotic treatment.
Intervention groups
Patients in the intervention group will receive 600 mg N-acetyl cysteine orally every 12 hours for 14 days in addition to routine treatments. In the control group, routine diabetic foot ulcer treatments will be performed.
Main outcome variables
Wound size, number of wounds and healing time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220928056051N2
Registration date:2023-01-08, 1401/10/18
Registration timing:prospective
Last update:2023-01-08, 1401/10/18
Update count:0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Laya Hooshmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
hooshmand.l@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the N-Acetyl cysteine effect on therapeutic outcome of diabetic foot ulcers
Public title
Assessment of the N-Acetyl cysteine effect on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Grade 3 or 4 diabetic foot ulcer according to Wagner criteria
Exclusion criteria:
Allergy to N-Acetyl cysteine and sulfur products
Pregnancy and breastfeeding
Other causes of ulcers except diabetes include trauma and others
A generated- ulcers skin disease
Impossibility of taking tablets orally
Patients treated with chemotherapy or radiotherapy drugs
Taking drugs such as: corticosteroids at a minimum dose equivalent to 40 milligrams of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab
Hospitalized for a diabetic foot ulcer in the last month and receiving injection antibiotic treatment
Stenosis and severe cramping of the lower limbs vessels based on vascular sonography
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control 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. Patients will be allocated to intervention or control groups based on generated numbers.
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
کمیته اخلاق بیمارستان امام خمینی، دانشگاه علوم پزشکی ارومیه
Intervention group: Patients in the intervention group will receive 600 mg N-acetyl cysteine orally every 12 hours for 14 days in addition to routine treatments.
Category
Treatment - Drugs
2
Description
Control group: In the control group, routine diabetic foot ulcer treatments will be performed.