Protocol summary

Study aim
Determining the effect of vitamin C on the healing of diabetic foot ulcers and the quality of life of patients with diabetes
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 60 patients. The block method was used for randomization
Settings and conduct
This study will be conducted in the hospital clinic of Mashhad city. Participants will be included in this study after explaining the objectives and obtaining informed consent. They will be divided into intervention and control groups by block randomization method. Patients in both groups will complete the demographic information and quality of life questionnaire before the intervention. Patients will receive their original treatment. At the end of the 8th week, the extent of the wound will be checked and the quality of life questionnaire will be completed. The conditions of the patients before and after the intervention will be compared in and between the groups.
Participants/Inclusion and exclusion criteria
Presence of diabetic foot ulcer - Ankle-brachial index greater than or equal to 0.7 - Absence of gangrene, severe ischemia, and persistent fever over 38°C - No smoking, alcohol, or drug addiction - Patient willingness and written informed consent; Previous use of vitamin C supplements - Presence of confirmed osteomyelitis - Patients with renal failure, liver failure, immune system failure, cancer and severe peripheral arterial disease - Pregnancy or lactating
Intervention groups
Patients in the intervention group will use one slow-release capsule of vitamin C 500 mg daily for 8 weeks Patients in the control group will also use an inactive placebo capsule (appearance, color and size) made in the Industrial Pharmaceutical Laboratory of Mashhad University of Medical Sciences daily for 8 weeks
Main outcome variables
Wound extent (length and width); percentage of complete wound healing; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210315050706N2
Registration date: 2024-04-06, 1403/01/18
Registration timing: prospective

Last update: 2024-04-06, 1403/01/18
Update count: 0
Registration date
2024-04-06, 1403/01/18
Registrant information
Name
Armin Nazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
nazeri.a.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin C for healing of diabetic foot ulcer and quality of life: a randomized, double-blind, placebo-controlled trial
Public title
The effect of Vitamin C for healing of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of diabetic foot ulcer; Wagner ulcer 1or 2 (classified according to the Wagner classification system) If more than one ulcer is present, the largest ulcer classified as Wagner 1 or 2 is selected The selected wound must be at least four centimeters away from a non-target wound and, according to the researcher, unlikely to merge with another wound within 8 weeks after randomization. A well-defined leg ulcer, circular or oval in shape (measurable with a simple ruler), located on the plantar, medial, or lateral surface of the foot (including all surfaces of the toes), and without bone exposure Measurement of wound area (length ᵡ width) between 2 cm2 and 20 cm2 The selected wound should not be clinically infected Ankle brachial index (ABI) greater than or equal to 0.7 Palpable Dorsalis Pedis pulse in both legs Male or female between 18 and 80 years old Avoiding the use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressants, and cytotoxic agents Absence of gangrene, severe ischemia, and persistent fever over 38°C No smoking, alcohol or drug addiction Patient willingness and written informed consent to participate in the study and take study pills, but no other vitamin supplements, during the study. (Persons taking vitamin supplements were eligible after a two-month abstinence period)
Exclusion criteria:
Previous use of vitamin C supplements Confirmed presence of osteomyelitis, or if osteomyelitis is suspected Patients with renal failure, liver failure, immune system failure, cancer and severe peripheral arterial disease The patient's blood vessels are non-compressible for ABI testing According to Sander's classification system, the patient should be diagnosed with active Charcot A patient with mental, developmental, physical and emotional disorders The individual's unwillingness to continue to cooperate during the study or if they have not completed their treatment Pregnancy or lactating
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 10 blocks of size 4 and 10 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks with size two are 1: AB and 2: BA. The list of blocks with size four are: 1:AABB, 2:ABBA, 3:BBAA, 4:BAAB, 5:BABA, 6:ABAB. To select blocks of size 2, 10 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 10 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4, and if the selected number is 2, is the second block and so on for other blocks. are selected. The generated allocation sequence is placed in sealed envelopes and will be reopened when the patients enter the study
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the researcher, the outcome assessor, and the clinical caregiver (wound nurse) were blinded to the group position of the patients, as well as the nature of the vitamin C tablet or placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.MUMS.REC.1402.344

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Primary outcomes

1

Description
Wound size (length and width)
Timepoint
At the beginning of the study and 8 weeks after the start of the intervention
Method of measurement
Ruler or 3D camera

Secondary outcomes

1

Description
Quality of Life
Timepoint
At the beginning of the study and 8 weeks after the start of the intervention
Method of measurement
SF-36 questionnaire

2

Description
Percentage of complete wound healing
Timepoint
The beginning of the intervention until 16 weeks after the start of the intervention (8 weeks after the end of the intervention as a follow-up)
Method of measurement
The percentage of wound size reduction compared to the initial size

Intervention groups

1

Description
Intervention group: Patients in the intervention group will use one slow-release capsule of vitamin C 500 mg daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients in the control group will also use a similar inactive placebo capsule (appearance, color and size) made in the pharmaceutical industrial laboratory of Mashhad University of Medical Sciences on a daily basis for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Velayat Hospital
Full name of responsible person
Mohammad Mahdi Kamyar
Street address
intersection of Namaz Boulevard and Shahid Kaveh Boulevard (next to Akbar Hospital), Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3872 2140
Fax
+98 51 3872 2139
Email
kamyarmm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kamyar
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3879 5031
Email
kamyarmm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Armin Nazeri
Position
Other
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+985138049
Email
armin.nazeri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kamyar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+985138049
Email
kamyarmm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Armin Nazeri
Position
Other
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴)
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+985138049
Email
armin.nazeri@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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