Evaluation of Efficacy of SIKADERM Topical Ointment in comparison with Standard Treatment in Enhancing Wound Healing and Managing Infections in Diabetic Foot Ulcers: A Double Blinded Randomized Clinical Trial
Assessing the effectiveness of Sikaderm topical ointment in comparison with standard treatment in healing process of diabetic foot ulcers
Design
The clinical trial consists of a control group, with parallel groups, double-blinded, randomized. Online sites will be used for random allocation.
Settings and conduct
100 patients will be randomly assigned to a control group (standard treatment + ointment dressing) or an intervention group (standard treatment + Sikaderm ointment), with 50 patients in each group. Standard treatment involves washing with normal saline, sharp debridement, and routine dressing
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Individuals of age 30 to 65
- Patients with diabetic neuropathic and neuroischemic foot ulcers
- Patients with Wagner Grade 1 and 2 Diabetic Foot Ulcer
- Patients with PEDIS Grade 1 and 2 Diabetic Foot Ulcer
- Patient with the hemoglobin A1c less than and equal to 8.5
Exclusion criteria:
- Patient's unwillingness to cooperate
- Patients with cutaneous allergies
- Hospitalization for reasons other than diabetic foot ulcers
- Suffering from coagulation / vascular diseases
Intervention groups
Intervention and control groups are followed up weekly (in-person) for 4 weeks, and adverse events are recorded in the CRF questionnaire. The Sikaderm ointment dressing is changed once daily (every 24 hours). During the study, wound cultures are taken three times (0-2-4) from each patient's ulcer. These measurements are taken before starting the treatment, in the second week, and in the fourth week of the study. Throughout the study and also in the fifth week, patients will be followed up for the presence of adverse events.
Main outcome variables
Using Sikaderm topical ointment to expedite the healing process of diabetic foot ulcers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080904001199N9
Registration date:2024-02-15, 1402/11/26
Registration timing:prospective
Last update:2024-02-15, 1402/11/26
Update count:0
Registration date
2024-02-15, 1402/11/26
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
2024-03-05, 1402/12/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of SIKADERM Topical Ointment in comparison with Standard Treatment in Enhancing Wound Healing and Managing Infections in Diabetic Foot Ulcers: A Double Blinded Randomized Clinical Trial
Public title
Evaluation of Efficacy of SIKADERM Topical Ointment in comparison with Standard Treatment in Enhancing Wound Healing and Managing Infections in Diabetic Foot Ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals of age 30 to 65
Patients with diabetic neuropathic and neuroischemic foot ulcers
Patients with Wagner Grade 1 and 2 Diabetic Foot Ulcer
Patients with PEDIS Grade 1 and 2 Diabetic Foot Ulcer
Patient with the hemoglobin A1c less than and equal to 8.5
Exclusion criteria:
Patient's unwillingness to cooperate
Patients with cutaneous allergies
Hospitalization for reasons other than diabetic foot ulcers
Suffering from coagulation / vascular diseases
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients with foot ulcers are randomly divided into two groups "control, intervention" after examination and if they meet the criteria to enter the trial. The random block method with blocks of four will be used by using online randomization websites for random allocation. A numerical code is defined for the random sequence, and people receive the numerical code in the same order as they enter and are placed in the corresponding group according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients participating in the study, as well as the study's executive factors, the analyst performing statistical analysis, and the nurse and physician, will not be informed of the random sequence code. In this study, the nurse (physician) measuring the wound size, microbiology laboratory personnel, and the statistical analyst are unaware of the method of allocating patients to study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Endocrine & Metabolism Research Institute - Tehran University of Medic
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
2024-02-06, 1402/11/17
Ethics committee reference number
IR.TUMS.EMRI.REC.1402.123
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E10.621
ICD-10 code description
Type 1 diabetes mellitus with foot ulcer
2
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
The bacterial load on the wound surface
Timepoint
Before the intervention - the second week after the intervention- the fourth week after the intervention
Method of measurement
Microbial culture will be done using swap and agar medium. Bacterial colonies are reported qualitatively and quantitatively
2
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
Method of measurement
Using digital calipers and ImageJ software. After washing and debriding the wound to measure the surface of the wound, in addition to photography, a digital caliper is used to calculate the largest length and width of the wound. The depth of the wound is also measured and recorded using a probe
Secondary outcomes
1
Description
Side effects of treatment
Timepoint
throughout the intervention and the fifth week after the intervention
Method of measurement
There will be phone and in-person reviews. Registration is done in the case report form (CRF).
Intervention groups
1
Description
Control group: Control group: These patients will receive standard treatment including washing with normal saline, debridement and dressing. Every week, after performing sharp debridement and washing the wound with normal saline solution, the wound surface is appropriately dressed with placebo topical ointment. In addition, the patient changes the dressing every day during the week using saline solution and placebo ointment. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four weeks.
Category
Treatment - Drugs
2
Description
Intervention group: These patients will receive Sikaderm topical ointment in addition to standard treatment including washing with normal saline, debridement and dressing. Every week, after performing sharp debridement and washing the wound with normal saline solution, the wound surface is appropriately dressed with Sikaderm topical ointment. In addition, the patient changes the dressing every day during the week using saline solution and Sikaderm topical ointment. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr Mohammad Reza Amini
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Akam Darou Deylaman
Full name of responsible person
Vida Amirdavar
Street address
Tehran, Shemiranat County, Central District, Tajrish City, Hekmat Street, Shahid Amirhossein Karimi Street, Third Mohagheghi Dead-end, Unit 2.1, Floor 3, Apartment 6.
City
Tehran
Province
Tehran
Postal code
1938753565
Phone
+98 21 2239 5721
Email
vidaamirdavar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Akam Darou Deylaman
Proportion provided by this source
100
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Amini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
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 0038
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
Mohammad Reza Mohajeri Tehrani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Dr. shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Email
mrmohajeri@tums.ac.ir
Web page address
http://emri.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ozra Tabatabaei-Malazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
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
tabatabaeiml@sina.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