- Investigating the effect of Pistacia atlantica cream in the treatment of wounds in diabetic patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients.
Settings and conduct
Diabetic patients who refer to medical centers of Fasa University of Medical Sciences will be selected based on the entry and exit conditions. Participants and researchers are kept blinded.
Participants/Inclusion and exclusion criteria
Entry conditions:
- Patients with diabetic foot wounds aged between 20 and 55 years
- The patient's blood sugar should be under control, the blood sugar should be below 7.5 for three months
- Having a diabetic foot wounds without osteomyelitis
- Not using corticosteroids and immunosuppressive drugs
- Wound with Wegener grade 2
- Wounds in the lower limbs
- Not having a history of allergy to medicinal plants
- No history of liver and heart disease, pregnancy and pregnancy, porphyria and lupus malignancy
- No history of surgery in the last 6 months
- Being stable in terms of hemodynamics
Non-entry conditions
- Having osteomyelitis
- Use of corticosteroids and immunosuppressive drugs
- Wagner grade more than 2
- Wounds other than the lower limbs
- Having a history of liver and heart disease during pregnancy and pregnancy and malignancy, porphyria and lupus
Intervention groups
The control and intervention groups received antibiotic treatment for diabetic wounds with mupirocin cream and common treatments including antibiotic treatment with 25% Pistacia atlantica cream, respectively.
Main outcome variables
Wound size; infection; type of secretions; the amount of secretions; length of hospitalization; Underlying disease; redness of the wound; human; bruising around the wound; being warm around; ambient temperature; necrotic tissue; degree of neuropathy; Wagner class; intervention (receiving Pistacia atlantica cream)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240601061969N1
Registration date:2024-06-21, 1403/04/01
Registration timing:prospective
Last update:2024-06-21, 1403/04/01
Update count:0
Registration date
2024-06-21, 1403/04/01
Registrant information
Name
Sara Shafiee bidshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 6300
Email address
e.jahantab@fasau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Pistacia atlantica cream in the treatment of wounds in diabetic patients, a double-blind clinical study
Public title
Investigating the effect of Pistacia atlantica cream in the treatment of wounds in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcers aged between 20 and 55 years old (at most 2 weeks have passed since the onset of the ulcer)
The patient's blood sugar should be under control, the blood sugar should be below 7.5 for three months
Having diabetic foot ulcers without osteomyelitis (having various ulcers on the right or left foot with moderate inflammation that has not reached the stage of osteomyelitis)
Not using corticosteroids and immunosuppressive drugs
Wound with Wegener grade 2
Ulcers in the lower limbs
Not having a history of allergy to medicinal plants
Having no history of liver and heart disease, pregnancy and pregnancy, porphyria and lupus malignancy
No history of surgery in the last 6 months
Hemodynamically stable
Exclusion criteria:
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is such that 50 envelopes are prepared and in 25 of them 25 cards with the letter A as the control group and 25 cards with the letter B as the intervention group are written in the other 25 cases. It is put inside the envelope and the patients are asked to choose one at random. The letter written in the selected envelope indicates the participating group. It should be noted that the selection of cards will be done without placement.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants and researchers are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
74616-86688
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.FUMS.REC.1403.007
Health conditions studied
1
Description of health condition studied
diabetic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound size
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
ruler
2
Description
infection
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
3
Description
Type of secretions
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
4
Description
The amount of secretions
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
5
Description
Hospitalization day
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
6
Description
Background disease
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
7
Description
redness of the wound
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
8
Description
edema
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
9
Description
Bruising around the wound
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
10
Description
Being warm around
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
11
Description
Ambient temperature
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
thermometer
12
Description
Necrotic tissue
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
13
Description
The degree of neuropathy
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
14
Description
Wagner class
Timepoint
the beginning of the study (before the start of the intervention); 3; 5; 9; 13; 17; 21; 25; 30 days after starting to use the cream
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Antibiotic treatment with 25% Pistacia atlantica cream
Category
Treatment - Other
2
Description
Antibiotic treatment for diabetic ulcer with mupirocin cream
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali asr hospital
Full name of responsible person
Peyman Manouchehri
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 5012
Email
info@fums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Taherh Zebardast
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
7461750003
Phone
+98 71 5341 1010
Email
eh.hospital@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Akbar Farjadfar
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 6300
Email
research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Sara Shafiee Bidshahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 6300
Email
e.jahantab@fasau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sara Shafiee Bidshahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 6300
Email
e.jahantab@fasau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sara Shafiee Bidshahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 6300
Email
e.jahantab@fasau.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
Yes - There is 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
Part of the data, such as the main outcome, will be shared after the study
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analyzes that help improve results are allowed on the delivered data
From where data/document is obtainable
Applicants can refer to Fasa University of Medical Sciences.
Postal code: 86688-74616
Email: research@fums.ac.ir
Phone: 00987153316300
What processes are involved for a request to access data/document
The applicant receives the data for a maximum of 6 months from the time they apply