Evaluation of the effectiveness of the ozonized herbal (olive) medicine in comparison with standard treatment on healing of Diabetic Foot Ulcer: a randomized single-blind controlled trial
To evaluate the effectiveness of ozonized herbal (olive-based) medicine compared to standard treatment in the healing of diabetic foot ulcers.
Design
A randomized block design with blocks of four will be used. Numeric codes for the random sequence will be generated using online tools. Each participant entering the study will receive a numeric code in the order of their enrollment and will be allocated to their corresponding group based on the block sequence.
Settings and conduct
The nurse or physician attending to the patient will measure the wound size and record other relevant information. The microbiology laboratory staff and the statistical analyst will remain blinded to the allocation of patients to study groups. However, due to the visible differences in the appearance of the dressings, patient blinding is not feasible.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with neuropathic or neuroischemic diabetic foot ulcers with infection (including diabetic foot ulcers classified as PEDIS grade 1 or 2 or Dia Wagner grade 1 to 3)
Patients aged between 30 and 65 years.
Patients with HbA1c levels equal to or lesser than 8.5%.
exclusion criteria:
Lack of willingness to continue participation.
Diagnosis of COVID-19.
Attending clinic for reasons other than diabetic foot ulcers.
Coagulation disorders (due to the potential risk of bleeding and related complications during the debridement process).
History of skin allergies.
Intervention groups
standard treatment + dressing with ozonized herbal (olive-based) medicine
Main outcome variables
Ulcer area, Ulcer type, Ulcer grading, Duration of ulcer healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080904001199N10
Registration date:2024-11-24, 1403/09/04
Registration timing:registered_while_recruiting
Last update:2024-11-24, 1403/09/04
Update count:0
Registration date
2024-11-24, 1403/09/04
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
2024-11-05, 1403/08/15
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of the ozonized herbal (olive) medicine in comparison with standard treatment on healing of Diabetic Foot Ulcer: a randomized single-blind controlled trial
Public title
Evaluation of the effectiveness of the ozonized herbal (olive) medicine in comparison with standard treatment on healing of Diabetic Foot Ulcer: a randomized single-blind controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with neuropathic or neuroischemic diabetic foot ulcers with infection (including diabetic foot ulcers classified as PEDIS grade 1 or 2 or Dia Wagner grade 1 to 3)
Patients aged between 30 and 65 years.
Patients with HbA1c levels equal to or lesser than 8.5%.
Exclusion criteria:
Lack of willingness to continue participation.
Diagnosis of COVID-19.
Attending clinic for reasons other than diabetic foot ulcers.
Coagulation disorders (due to the potential risk of bleeding and related complications during the debridement process).
History of skin allergies.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized block design with blocks of four will be used. Numeric codes for the random sequence will be generated using online tools. Each participant entering the study will receive a numeric code in the order of their enrollment and will be allocated to their corresponding group based on the block sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The nurse or physician attending to the patient will measure the wound size and record other relevant information. The microbiology laboratory staff and the statistical analyst will remain blinded to the allocation of patients to study groups. However, due to the visible differences in the appearance of the dressings, patient blinding is not feasible.
Placebo
Not 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
No. 10, Al-e-Ahmad Highway and Chamran Highway intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Approval date
2024-11-09, 1403/08/19
Ethics committee reference number
IR.TUMS.EMRI.REC.1403.090
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
2
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E10.621
ICD-10 code description
Type 1 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Area of the diabetic foot ulcer
Timepoint
At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention
Method of measurement
Standard ruler
2
Description
Ulcer type (neuropathic/neuroischemic)
Timepoint
At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention
Method of measurement
Ankle –brachial index (ABI)
3
Description
Ulcer grading (Wagner and PEDIS system)
Timepoint
At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention
Method of measurement
Clinical assessment
4
Description
Duration of ulcer healing
Timepoint
At baseline (before the intervention) and at 1, 2, 3, and 4 weeks after the intervention
Method of measurement
Clinical assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: standard treatment + ozonized herbal (olive) medicine
Category
Treatment - Drugs
2
Description
Control group: standard treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center
Full name of responsible person
Mohammad Reza Amini
Street address
Diabetes and Metabolic Diseases Clinic, Corner of Heyat St., Shahrivar St., North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8833 8740
Fax
+98 21 8822 0052
Email
Diabetes.Research@yahoo.com
Web page address
https://drc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
FEDAR Pharmed Sadir Gharn
Full name of responsible person
Mahdieh Jafari
Street address
No. 3, 1st Floor, Unit 3, Shirin St., South Ararat St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994848484
Phone
+98 21 8804 7729
Email
info@feedarpharmed.com
Web page address
https://feedarpharmed.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
FEDAR Pharmed Sadir Gharn
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 and Diabetic Foot Research Group Manager
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
5th Floor, Dr. Shariati Hospital, North Kargar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0038
Fax
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 Amini
Position
Assistant Professor and Diabetic Foot Research Group Manager
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
5th Floor, Dr. Shariati Hospital, North Kargar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0038
Fax
Email
mramini@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Amini
Position
Assistant Professor and Diabetic Foot Research Group Manager
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
5th Floor, Dr. Shariati Hospital, North Kargar St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0038
Fax
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