Evaluation the effects of N-acetyl Cysteine supplementation on wound healing and inflammation in patients with diabetic foot ulcer
Design
Randomized Clinical trial with parallel group of 100patients, phase 3 with the computer-generated random numbers
Settings and conduct
This study is a clinical trial on 100 patients who have diabetic foot ulcer in Tehran, Loghman Hakim hospital.
Participants/Inclusion and exclusion criteria
Inclusion criterias: Patients over 18 years old hospitalized in the infectious, internal and orthopedic departments of Loghman Hospital who have type 2 diabetes and unhealed diabetic foot ulcers
Exclusion criterias: Patients with a history of taking N-acetylcysteine, vitamin D and vitamin C in the last 2 weeks, Patients with a history of allergy to N-acetylcysteine or its derivatives, Patients with a history of asthma and bronchospasm , Pregnant and lactating patients, Patients taking immunosuppressive drugs, Patients who are discharged from the hospital within 1 week, Patients who have serum creatinine concentration above 2 miligram per deciliter.
Intervention groups
Intervention group: In addition to receiving the prescribed treatments, patients with diabetic foot ulcer will receive N-acetyl cysteine made by Hakim Pharmaceutical company (Acestine Trade mark) at a dose of 600 mg every 8 hours orally during the hospitalization period. / Control group: Patients with diabetic foot ulcers will receive the prescribed treatments.
Main outcome variables
Area and depth of wound involvement; Inflammation factors including ESR and CRP; White Blood Cell; Edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130917014693N17
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of N-acetyl Cysteine supplementation on wound healing and inflammation in patients with diabetic foot ulcer
Public title
Evaluation the effects of N-acetyl Cysteine on diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized in the infectious, internal and orthopedic departments of Loghman Hospital who have type 2 diabetes and unhealed diabetic foot ulcers
Patients with grade 3 according to the PEDIS criteria
Patients with osteomyelitis involvement proven by MRI or clinical criteria
Patients with ankle-brachial pressure index (ABI) between 0.9 and 1.3
Patients who have signed the consent form
Exclusion criteria:
Patients with a history of taking N-acetylcysteine, vitamin D and vitamin C in the last 2 weeks
Patients with a history of allergy to N-acetylcysteine or its derivatives
Patients with a history of asthma and bronchospasm
Pregnant and lactating patients
Patients taking immunosuppressive drugs
Patients who are discharged from the hospital within 1 week
Patients who have serum creatinine concentration above 2mg/dL
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients into 2 groups is according to the block randomization method. In this method, patients are divided into blocks of 4. A website is used to prepare the randomized list.
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
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery - Shahid Beheshti Universit
Diabetes mellitus due to underlying condition with foot ulcer
Primary outcomes
1
Description
Area and depth of wound involvement
Timepoint
Duraing the study
Method of measurement
Sterile ruler
Secondary outcomes
1
Description
Inflammation factors including ESR (Erythrocyte sedimentation rate) and CRP (C-reactive protein)
Timepoint
Every other day the beginning of the drug administration to the end of the study
Method of measurement
Laboratory
2
Description
White Blood Cell
Timepoint
Every other day the beginning of the drug administration to the end of the study
Method of measurement
Laboratory
3
Description
Edema
Timepoint
Once daily from the beginning of the drug administration to the end of the study
Method of measurement
Meter
Intervention groups
1
Description
Intervention group: In addition to receiving the prescribed treatments, patients with diabetic foot ulcer will receive N-acetyl cysteine made by Hakim Pharmaceutical company (Acestine Trade mark) at a dose of 600 mg every 8 hours orally during the hospitalization period.
Category
Treatment - Drugs
2
Description
Control group: Patients with diabetic foot ulcers will receive the prescribed treatments.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Zahra Sahraei
Street address
Makhsus St ,Qazvin St ,Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Web page address
https://lhmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
z.sahraei@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
z.sahraei@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Zareiifar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Zareiifar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta analysis
From where data/document is obtainable
Dr. Zahra Sahraei, No.2660, Valieasr St, Shahid Beheshti University of Medical Sciences, School of Pharmacy, 3rd floor, Department of Clinical Pharmacy Zip Code: 1996835113 Telephone: +982188200209 Email: z.sahraei@sbmu.ac.ir
What processes are involved for a request to access data/document
Official letter to the researchers, then after 7 days, their request will be answered.