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Evaluating the effectiveness of nano silver spray on digital ulcers of patients with scleroderma

Protocol summary

Study aim
Evaluating the effectiveness of nano silver spray on digital ulcers of patients with scleroderma
Design
A placebo-controlled, randomized, double-blinded, phase 2-3 clinical trial on 50 patients. Block randomization was used for randomization.
Settings and conduct
The study will be conducted as a double-blind clinical trial in experimental and control groups. Fifty patients with finger ulcers, caused by scleroderma, who referred to rheumatology clinic of Imam Reza hospital, and met the study inclusion and exclusion criteria, will be included in the study. Then, they will be randomly assigned to experimental or control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients aged > 18 years 2. Patients with finger ulcers, caused by scleroderma, with mild to moderate severity (1-10 new ulcers in the fingers involving surface epithelial cells, the epidermis, the dermis, or the subcutaneous tissue) and without purulent discharge 3. Patients who signed our patient consent permission form. Exclusion criteria: 1. Patients with severe finger ulcers (more than 10 new ulcers in the fingers, extensive tissue destruction with damage to muscle, supporting structures (eg, tendon, joint capsule) and bone, necrosis and gangrene) Patients who do not use the spray regularly
Intervention groups
In the intervention group, patients use silver nanospray 4 times a day (every 6 hours) on the finger ulcers. In the control group, patients use placebo spray 4 times a day (every 6 hours) on the finger ulcers.
Main outcome variables
The size of ulcers, (DUS) digital ulcer score, the healing time of ulcers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191221045837N5
Registration date: 2023-09-09, 1402/06/18
Registration timing: prospective

Last update: 2023-09-09, 1402/06/18
Update count: 0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Zinat Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1584
Email address
heidarizn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of nano silver spray on digital ulcers of patients with scleroderma
Public title
Evaluating the effectiveness of silver spray in scleroderma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients aged > 18 years 2. Patients with finger ulcers, caused by scleroderma, with mild to moderate severity (1-10 new ulcers in the fingers involving surface epithelial cells, the epidermis, the dermis, or the subcutaneous tissue) and without purulent discharge 3. Patients who signed our patient consent permission form.
Exclusion criteria:
1. Patients with severe finger ulcers (more than 10 new ulcers in the fingers, extensive tissue destruction with damage to muscle, supporting structures (eg, tendon, joint capsule) and bone, necrosis and gangrene) Patients who do not use the spray regularly
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: To perform this method, the number of intervention groups (two groups A and B), the volume of each block (4 in each block) and sample size (50 patients) were entered into the website. Then, the site creates a randomization list of 13 blocks, each contains 4 patients
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blinded in which the subjects, evaluators, analysts, sample allocators will be unaware of the intervention and control groups. Drugs and placebo, numbered 1-50, will be identified and distinguished by the drug manufacturing company, which belong to the drug or placebo group based on a random list prepared from www.sealedenvelope.com. The physician, patients, and analyst will remain unaware of the type of formulation until the work is completed. Patients receive one of the medicine containers, number 1-50, respectively. The list will be decrypted when completed.
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
Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2023-08-19, 1402/05/28
Ethics committee reference number
IR.MUMS.REC.1402.138

Health conditions studied

1

Description of health condition studied
scleroderma
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]

Primary outcomes

1

Description
The size of ulcers
Timepoint
weekly
Method of measurement
Length x Width: Measure the greatest length (head to toe) and the greatest width (side to side) using a centimeter ruler.

2

Description
(DUS) digital ulcer score
Timepoint
weekly
Method of measurement
Length x depth of ulcer

3

Description
The healing time of ulcers
Timepoint
weekly
Method of measurement
Observing the appearance of the ulcer

Secondary outcomes

1

Description
Intensity of pain in patients with ulcers
Timepoint
weekly
Method of measurement
visual analogue scale (VAS)

2

Description
The quality of life of patients
Timepoint
weekly
Method of measurement
Health-Related Quality of Life (HRQOL) questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group, patients use silver nanospray 4 times a day (every 6 hours) on the finger ulcers.
Category
Treatment - Drugs

2

Description
Control group: In the control group, patients use placebo spray 4 times a day (every 6 hours) on the finger ulcers.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Zinat Heidari
Street address
Imam Reza hospital, Imam Reza Square, Ibn-e Sina Avenue, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Heidarizn@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Moohebati
Street address
Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 1538
Email
vcresraech@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
Zinat Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
heidarizn@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zinat Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
heidarizn@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zinat Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
heidarizn@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of study, all medical records of patients will be shared.
When the data will become available and for how long
The access period starts 6 months after the publication.
To whom data/document is available
Researchers affiliated to academic, scientific and industrial institutes
Under which criteria data/document could be used
No one is allowed to use the documents except the principal researcher.
From where data/document is obtainable
Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir
What processes are involved for a request to access data/document
Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir
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