The effect of gelatin dressing containing nanocurcumin compared to dressing containing mupirocin in improving diabetic foot ulcer in patients with superficial diabetic foot ulcer (grade 1)
Evaluating the effect of gelatin dressing containing nanocurcumin on the healing of superficial diabetic foot ulcers (Grade 1)
Design
Clinical trial with control group, with parallel groups, randomized on 168 patients
Settings and conduct
Patients will be randomly divided into 2 groups: In the test group, a new gelatin dressing containing nanocurcumin will be used. In the control group, mupirocin will be used as a common treatment. Dressings are applied in selected groups and an elastic adhesive bandage is used to stabilize and secure the dressings on the wound area. Control dressings are changed daily, but test dressings are not. wound healing process; Biodegradability and blood clotting are evaluated and recorded at the intended dressing site within ten days. Also, to evaluate blood factors, blood samples are taken from patients on the 1st, 3rd, 7th, and 14th days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic foot ulcer grade 1 according to Wegener's criteria
Exit criteria:
History or having deep vein thrombosis,
Bleeding and bleeding disorders of leg ulcers,
Having vascular problems for any reason other than diabetes
Ulcers caused by skin cancer and trauma
Use of immunosuppressive drugs
Intervention groups
Intervention group: In patients of this group, a new gelatin dressing containing nanocurcumin will be used on the diabetic foot ulcer.
Control group: In patients of this group, mupirocin and normal dressing will be used on the diabetic foot ulcer.
Main outcome variables
Wound healing process by measuring wound diameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N6
Registration date:2023-04-03, 1402/01/14
Registration timing:prospective
Last update:2023-04-03, 1402/01/14
Update count:0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-19, 1402/02/29
Expected recruitment end date
2024-04-17, 1403/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gelatin dressing containing nanocurcumin compared to dressing containing mupirocin in improving diabetic foot ulcer in patients with superficial diabetic foot ulcer (grade 1)
Public title
The effect of a new gelatin dressing containing nanocurcumin in patients with superficial diabetic foot ulcers (grade 1)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic foot ulcer grade 1 according to Wegener criteria
Exclusion criteria:
History or deep vein thrombosis
Bleeding and bleeding disorders of leg ulcers
Having vascular problems for any reason other than diabetes
Ulcers caused by skin cancer and trauma
Use of immunosuppressive drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using statistical software
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St, Daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-12-25, 1401/10/04
Ethics committee reference number
IR.TBZMED.REC.1401.876
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E08.11
ICD-10 code description
Diabetes mellitus due to underlying condition with ketoacidosis with coma
Primary outcomes
1
Description
Diabetic foot wound healing process
Timepoint
on days 1, 3, 7, and 14 after placing the dressing
Method of measurement
By measuring wound diameter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients, a new gelatin dressing containing nanocurcumin will be used on the wound.
Category
Treatment - Drugs
2
Description
Control group: In patients, ordinary dressing and mupirocin medicine will be used on the wound.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Nasser Agha Mohammadzadeh
Street address
Tabriz University of Medical Sciences, Golgasht St, Daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
maleki.s.89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Golgasht St, Daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nasser Agha Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult glands and metabolism
Street address
Tabriz University of Medical Sciences, Golgasht St, Daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
nmzmd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
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
The data will be published as an article.
When the data will become available and for how long
After the final publication of the article resulting from the data.
To whom data/document is available
Public
Under which criteria data/document could be used
For use in research articles and systematic reviews with citation.
From where data/document is obtainable
Dr. Solmaz Maleki Dizaj, Tabriz Faculty of Dentistry
What processes are involved for a request to access data/document