Determination of the effect of ANSIL solution (silver nanoparticle) on the severity of diabetic foot ulcers
Design
A clinical trial with a control group with parallel groups, double-blind, randomized, phase 3 on the sample size with 80 patients that randomized with GraphPad software.
Settings and conduct
This is a double-blind, placebo-randomized study using ANCIL solution or placebo in people with diabetic foot ulcers. Subjects are randomly assigned to intervention and control groups. Patients referred to Imam Reza Hospital of Tabriz University of Medical Sciences with signs and symptoms related to diabetic ulcers are included in the study through include/exclusion criteria and with informed written consent.
Participants/Inclusion and exclusion criteria
Patients with diabetes who take insulin and have diabetic foot ulcers and are in the age range of 18 to 80 years. Patients with infectious wounds, sensitivity to topical formulation Patients who need surgery for their wounds are excluded from the study.
Intervention groups
Group 1: 20 patients with diabetic foot ulcers receive 50ppm doses of ANCIL solution twice a day for 28 days.
Group 2: 20 patients with diabetic foot ulcers receive 100ppm dose of ANCIL solution twice a day for 28days
Group 3: 20 patients with diabetic foot ulcers receive 150ppm doses of ANCILsolution twice a day for 28days.
Control group: Treatment of diabetic foot ulcers in 20 patients in a way other than the mentioned method for28days.
Main outcome variables
The severity of a diabetic foot ulcer is measured using the Texas Scoring System.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N9
Registration date:2021-10-11, 1400/07/19
Registration timing:prospective
Last update:2021-10-11, 1400/07/19
Update count:0
Registration date
2021-10-11, 1400/07/19
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-16, 1400/07/24
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ANSIL(Silver nanoparticles) solution on Diabetic foot wounds: A double-blind clinical trial
Public title
Effect of ANCIL on diabetic foot wounds
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients taking insulin with diabetic wound
Age range 18 to 80 years
Exclusion criteria:
Patients with infectious wounds
Sensitivity to topical formulations
Patients who need surgery for their wounds
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using simple randomization using GraphPad software and by a secretary who does not interfere with other stages of the investigation. People will be randomly divided into groups A, B, C, D.
Blinding (investigator's opinion)
Double blinded
Blinding description
A solution that has an active ingredient in ANCIL with a solution that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the manufacturer company of the solution). The important point is that the patient is told that the solution used for the patient may be medication or medication. Clinicians or outcome assessors and blind patients will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medic
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.TBZMED.REC.1399.1169
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcers
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
The severity of a diabetic foot ulcer is measured using the Texas Scoring System.
Timepoint
Before the intervention and 7, 14, 21, and 28 days after the intervention
Method of measurement
The severity of diabetic foot ulcers in patients receiving ANCIL and placebo solution before the intervention and on days 7, 14, 21, and 28 after the intervention is measured using the Texas scoring system. Texas scoring system for diabetic foot ulcers to 4 degrees (0 to 3 Grade 1 is classified according to wound depth, infection, and ischemia as Grade 0 before or after the wound has healed, Grade 1 of a superficial wound that has not involved a tendon, capsule, or bone. Grade 2: The wound has penetrated a tendon or capsule. Grade 3: The wound has penetrated the bone or joint. Stage A: clean wound, Stage B: non-infectious and non-ischemic, Stage C: ischemic and non-ischemic, Stage D: Infectious and ischemic wound.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients with diabetic foot ulcer receive50ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening.
Category
Treatment - Drugs
2
Description
Intervention group: 20 patients with diabetic foot ulcer receive100ppm of ANCIL solution twice a day for 28days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening.
Category
Treatment - Drugs
3
Description
Intervention group: 20 patients with diabetic foot ulcer receive150ppm of ANCIL solution twice a day for 30 days and bandaged on the wound. ANCIL solution: ASEPE company introduces ANSIL for the treatment and repair of damaged tissues caused by diabetic wounds, bedsores, and injuries caused by severe burns. Various substances are used in the solution, including plant extracts of silymarin, zinc oxide, silver, ascorbic acid, glycerin, alpha tocopherol, retinoids, and phylloquinone. The type of material and their composition determine that it has the greatest effect on wound healing and strengthening.
Category
Treatment - Drugs
4
Description
Control group: Treatment of diabetic foot ulcers in 20 patients in a way other than the mentioned method for 28days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Manouchehr Khoshbaten
Street address
Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
reasearch-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
Shima Khademi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5158375751
Phone
+98 41 3662 8155
Email
Khademishima94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shima Khademi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5158375751
Phone
0416628155
Email
Khademishima94@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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data will be shared.
When the data will become available and for how long
2023-2024
To whom data/document is available
Researchers and academic staffs
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Request via email: Khademishima94@gmail.com
Shima Khademi
What processes are involved for a request to access data/document
Request via email: Khademishima94@gmail.com
Shima Khademi