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Investigating the effectiveness of Alovera spray on diabetic foot ulcers

Protocol summary

Study aim
Determining the effect of ALOVERA spray on the treatment of Diabetic Foot Ulcers
Design
A clinical trial with a control group, with parallel, single-blind, randomized groups, will be conducted on 180 patients with DFUs. Block randomization method and https://www.sealedenvelope.com was used to randomize the samples.
Settings and conduct
180 diabetic patients with DFU are selected with the inclusion criteria and will be randomly divided into 3 groups [Control groups, intervention 1 (silver nanoparticles) and intervention 2 (hypochlorous acid] using the randomized block method. Patients will be followed up and treated during 5 sessions as weekly visits. The reduction of bacterial load and wound surface will be measured at the beginning, second week, and at fifth week.
Participants/Inclusion and exclusion criteria
Patients with neuropathic and neuroischemic diabetic foot ulcers, patients with Pedis grade 1 and 2 diabetic foot ulcers, patients with Wegener grade 1 to 3 diabetic foot ulcers
Intervention groups
Control group: In the weekly visit, the wound will be washed with N/S, then sharp debridement and appropriate dressing will be used. During the week, the patient will wash the wound 3 times and change the dressing. Intervention group 1: In the weekly visit, the wound is washed with N/S and Silvosept spray silver (Chitotech) is used to disinfect the wound, and then sharp debridement and dressing suitable for the patient will be used. Intervention group 2: In the weekly visit, the wound is washed with N/S and ALOVERA spray (Negin Daro Azerbaijan Company) is used to disinfect the wound, and then sharp debridement and then appropriate dressing for the patient will be used. In the intervention groups, the patient will wash, disinfect and change the dressing 3 times in a week. The duration of intervention is 5 weeks.
Main outcome variables
Wound area & bacterial load on the wound surface

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080904001199N7
Registration date: 2023-04-30, 1402/02/10
Registration timing: prospective

Last update: 2023-04-30, 1402/02/10
Update count: 0
Registration date
2023-04-30, 1402/02/10
Registrant information
Name
Mohammad Reza Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0038
Email address
mramini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Alovera spray on diabetic foot ulcers
Public title
Investigating the effectiveness of Alovera spray on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic neuropathic and neuroischemic foot ulcers PEDIS Grade 1&2 Diabetic Foot Ulcer Wagner Grade 1, 2 and 3 Diabetic Foot Ulcer
Exclusion criteria:
Getting infected with Covid-19
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to the diabetic foot ulcer clinic after selection based on inclusion and exclusion criteria are divided into three groups control, intervention 1, and intervention 2 using the Block Randomization method and blocks of 6. Using the study randomization available at https://www.sealedenvelope.com/ we will create sequences and blocks of 6 for randomization. Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 12 Dec 2022].
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, three methods will be used to wash and disinfect the wound surface. After a general explanation to the patients about the method and type of treatment in this plan, the patients will be randomly assigned to treatment groups based on blocks by the principal researcher. The doctor and nurse have no role in choosing the treatment group, but they know which patients are in the intervention group and which are in the control groups. All three groups are given unlabeled sprays. Neither patients nor their families are aware of what type of spray they are using. The results of the study and grouping of patients are recorded as a code, so the data analyst is also unaware of the type of group therapy.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Endocrinology and Metabolism Research Institute, Tehran University of Medica
Street address
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411713137
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.TUMS.EMRI.REC.1401.151

Health conditions studied

1

Description of health condition studied
Diabetic Foot Ulcers
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications

Primary outcomes

1

Description
wound area
Timepoint
Before the intervention - the first week after the intervention - the second week after the intervention - the third week after the intervention - the fourth week after the intervention - the fifth week after the intervention
Method of measurement
Using a ruler and ImageJ software

2

Description
The bacterial load on the wound surface
Timepoint
Before the intervention - the second week after the intervention - the fifth week after the intervention
Method of measurement
Microbial culture will be done using swap and agar medium.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In these patients, standard treatment (washing with normal saline, debridement and dressing) will be performed. Wound assessment will be done for patients during 5 sessions as weekly visits using the Triangle Wound Assessment tool. In every weekly visit, while washing the wound with normal saline solution and performing sharp debridement, the wound surface is covered with a suitable dressing. Meanwhile, the patient will use normal saline solution every other day during the week when changing the dressing (3 times). In each visit, the wound surface is also measured and recorded. Microbial culture will be done at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks.
Category
Treatment - Drugs

2

Description
Intervention group 1: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using Silvocept spray with the main composition of silver (Chitotech company). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after sharp debridement, the surface of the wound is covered with gauze impregnated with Silvocept for 3-4 minutes and finally the surface of the wound is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks.
Category
Treatment - Drugs

3

Description
Intervention group 2: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using ALOVERA spray (Negin Daro Azerbaijan). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after debridement, the wound surface is covered with gauze soaked in ALOVERA for 3-4 minutes and finally the wound surface is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic, Diabetes Research Center, Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr Mohammad Reza Mohajeri Tehrani
Street address
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
mrmohajeri@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
6th floor, Research Deputy, Central Office of TUMS,keshavarz Blvd., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
30
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

2

Sponsor
Name of organization / entity
Negin Daro Azerbaijan CO
Full name of responsible person
Mir Ali Asghar Seyed Hosseini
Street address
4th floor, No. 27, Goya Street, Imam Khomeini Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138969387
Phone
+98 914 894 2717
Email
a.hoseini1397@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Negin Daro Azerbaijan CO
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Amini
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Diabetic Foot
Street address
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
mramini@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Mohajeri Tehrani
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
mrmohajeri@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Amini
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Diabetic Foot
Street address
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St.,Enghelab Square, Tehran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
mramini@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical considerations
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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