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IRCT20230111057111N1 IRCT 2023-01-26 Islamic Azad University Investigating the effect of herbal and animal ointment in diabetic foot ulcer patients Phase I&II study of clinical trial safety and efficacy assessment of ointment made from extracted Shikonin in Alosa branschnikowi and Pusa capsica in patients with diabetic foot ulcers. 2023-01-31 anticipated 40 Complete https://irct.ir/trial/68030 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this research, in order to allocate patients to intervention and control groups, a block randomization approach will be used in a parallel way and random allocation rule. We will consider the size of the blocks randomly with a size of 4 or 6 , and various packages available in R software will be used to generate random numbers. The output of odd numbers will be classified in the intervention group and the output of even numbers will be classified in the control group. Allocation concealment method: There is no concealment. 1-2 Diabetes. Intervention 1: Intervention group: The intervention group received traditional treatment including washing twice a day with normal saline and keeping the wound clean and dry after that using the planned ointment twice a day for one month will be observed. The method of using the ointment is directly on the wound. The usual demographic information specified in the patient file is taken from the people, which includes: age, gender, occupation, education level, marital status, date and time, depth and percentage. Safety monitoring is verified by checklist in 4 stages (first day and 7, 14, 28), which includes evaluation of local and systemic side effects. Effective monitoring is done by the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcers. The specialist will visit the patients to check the healing of the wound in 4 stages (the first, seventh, twenty-eighth, and sixtieth day).The presence of long-chain fats in the composition of the used fish oil keeps the wound moist and prevents the formation of scars during healing. This composition contains Eqiumrussicum plant consist of naphthoquinine and allantoin substances with the property of stimulating regeneration by rapid growth of the epidermis and mesoderm in honey base as a stimulant, antibiotic and stabilizer. Intervention 2: Control group: The control group received traditional treatment including washing twice a day with normal saline and keeping the wound clean and dry , and if necessary, bandaging with sterile gauze. Yes - There is a plan to make this available What will be shared: After deidentifying people, all the data obtained from the research, including the demographic information of the samples, clinical information and the results of the intervention can be shared. When: It is possible to access the results after nine to twelve months from the publication of the results. To whom: Researchers in academic centers and scientific research centers. Conditions: In order to data comparison in similar studies, the researchers of academic centers and scientific research centers have the possibility to receive data and re-analyze it if they comply with the principles of ethics in research. Where to obtain: Dr Mohammad Zaefizadeh with below email address: mzaefi@gmail.com and phone number +98 9144514378 How to obtain: Researchers should send a written request to receive data to the relevant email address.A week after receiving an email , it will take action. Comments:
public Amin Bakhshizadeh Imcheh
No.4 , Notash alley, Golmoghan bridge , Shahid barzegar street , Shohada highway
Ardabil Iran (Islamic Republic of) 5616636316 +98 45 3342 3240 bakhshizadeh.dr@gmail.com Islamic Azad University scientific Dr Mohammad Zaefizadeh
Basij square
Ardabil Iran (Islamic Republic of) ۵۶۱۵۷۳۱۵۶۷ +98 45 3342 3240 mzaefi@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Having a chronic diabetic foot ulcer on an outpatient basis Age range from 30 to 80 years Having a single wound in the legs and extremities (fingers, soles, heels, on the toes) that has not healed for at least 4 weeks Having a body mass index of 18-35 30 years 80 years Both The presence of a wound with an active infection requires receiving intravenous antibiotics Gangrene requiring amputation Smoking, alcohol and drug addiction Taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. Having concurrent disease L97 Ulcer of lower limb, not elsewhere classified Treatment - Other Treatment - Other Intervention group: The intervention group received traditional treatment including washing twice a day with normal saline and keeping the wound clean and dry after that using the planned ointment twice a day for one month will be observed. The method of using the ointment is directly on the wound. The usual demographic information specified in the patient file is taken from the people, which includes: age, gender, occupation, education level, marital status, date and time, depth and percentage. Safety monitoring is verified by checklist in 4 stages (first day and 7, 14, 28), which includes evaluation of local and systemic side effects. Effective monitoring is done by the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcers. The specialist will visit the patients to check the healing of the wound in 4 stages (the first, seventh, twenty-eighth, and sixtieth day).The presence of long-chain fats in the composition of the used fish oil keeps the wound moist and prevents the formation of scars during healing. This composition contains Eqiumrussicum plant consist of naphthoquinine and allantoin substances with the property of stimulating regeneration by rapid growth of the epidermis and mesoderm in honey base as a stimulant, antibiotic and stabilizer. Control group: The control group received traditional treatment including washing twice a day with normal saline and keeping the wound clean and dry , and if necessary, bandaging with sterile gauze. Size of diabetic foot ulcer. Timepoint: Measurement of diabetic foot ulcer at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer. Local infection of diabetic foot ulcer. Timepoint: Investigation of wound infection at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer. Granulation tissue formation. Timepoint: Examination of granulation tissue formation at the beginning of the study and then on days 7, 14 and 28. Method of measurement: Based on the examination by specialist and the checklist taken from Fermin Digizaz's research called the scoring checklist system for the healing process of diabetic foot ulcer. The duration of complete healing of diabetic foot ulcer. Timepoint: At the beginning of the study and then on days 7, 14 ,28 and 60. Method of measurement: Based on the examination of the attending physician. Islamic Azad University Approved 2022-12-20 Research Ethics Committees of Islamic Azad University- Ardabil Branch Basij square Ardabil Ardabil Iran (Islamic Republic of)