Clinical evaluation of therapeutic effects of bio-complex on non ischemic diabetic foot ulcers
Design
In this study, 60 patients who referred for surgery were divided into two groups of control and intervention and four randomized blocks were used for randomization. A double-blind study will be.
Settings and conduct
This study , which is carried out at the Sina Hospital. Medical ethics and Consent is under supervision of the Medical Ethics Committee of the Tehran University of Medical Sciences. The study is a randomized, double blind, clinical trial with two intervention and control groups. Patients are randomly divided into two groups of 30. Randomly, 30 people will be in the intervention group and 30 will be in the control group. The control group treatment is Vaseline. In this study, the Patients, Researcher and Therapist are blinded. Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1- Is Come for Surgery 2- The Lesion Not be Malignant 3- No Specific or Immunosuppressive Disorders 4- Not be Pregnant or in Lactation 5- Not Use Any Specific Drug .
Exclusion Criteria: 1- The Ability to Create Colloid or Scar from the Injuries 2- The presence of Underlying Disease 3- Previous or Current History of Scleroderma 4- Previous Radiotherapy 5- Use Immunosuppressive Medicine or Have Immunodeficiency Disorders 6- Pregnancy or Lactation 7- Use Specific Drug 8- Dissatisfaction to continue use ointment
Intervention groups
The intervention group in this study is a randomly selected 30-person group that uses an alternative medicine to improve the wound healing process. The control group is a randomly selected 30-person group that uses conventional treatment Vaseline.
Main outcome variables
Less pain; Heal faster
General information
Reason for update
Acronym
Minhal
IRCT registration information
IRCT registration number:IRCT20160118026096N2
Registration date:2020-12-14, 1399/09/24
Registration timing:prospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 0598
Email address
takzaree@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of therapeutic effects of emulsion bio-complex on non ischemic diabetic foot ulcers
Public title
The effect of emulsion on the Process of diabetic wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Is Come for Surgery .The Lesion Not be Malignant No Specific or Immunosuppressive Disorders Not be Pregnant or in Lactation Not Use Any Specific Drug .
Exclusion criteria:
The Ability to Create Colloid or Scar from the Injuries The presence of Underlying Disease Previous or Current History of Scleroderma Previous Radiotherapy Use Immunosuppressive Medicine or Have Immunodeficiency Disorders Pregnancy or Lactation Use Specific Drug Dissatisfaction to continue use ointment
Age
From 25 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be generated using Excel software. In order to apply concealment in the randomization process, sealed envelopes will be used, and therefore, before choosing a person, one will not be aware of the type of treatment he will receive.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.741
Health conditions studied
1
Description of health condition studied
Diabetic Wound Healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound Surface
Timepoint
Day one (surgery day), Day 1 , 15 and 45 after surgery
Method of measurement
Wound healing is evaluated by measuring the wound surface, the percentage of wound healing, and the length of time needed for closure and complete repair of the wound. The surface of the wound is measured on days 1, 4, 7 and 14 after the surgery with Ferguson and Logan method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group in this study is a randomly selected 30-person group that uses an alternative medicine to improve the wound healing process. The control group is a randomly selected 30-person group that uses conventional treatment Vaseline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Nasrin Takzaree
Street address
Hasanabad Sq., District 12., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
sinahospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 218953008
Email
takzaree@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Tehran-School of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Email
takzaree@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
No.10 ,Porsina Ave.Tehran University of Medical Sciences,School of Medicine
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Email
takzaree@tums.ac.ir
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
No - There is not 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
Patient recovery results
When the data will become available and for how long
En 6 months after printing
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Only recovery results are reported
From where data/document is obtainable
takzaree@tums.ac.ir
What processes are involved for a request to access data/document