]>
IRCT20220310054247N1 IRCT 2022-06-06 Karaj University of Medical Sciences Effect of a topical gel containing Sumac extract and Cloxacillin on diabetic foot ulcer Investigating the effect of a topical gel containing Sumac extract and Cloxacillin on diabetic foot ulcer: a double-blind placebo-controlled trial 2022-06-05 anticipated 66 Complete https://irct.ir/trial/62428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Multi-digit numerical codes (barcodes) are written on the packages that only the main person in charge of the research can open the codes if necessary and the type of medicine is specified. The codes are arranged in such a way that in the first ten codes, five packages contain one of the drugs and the other five packages contain the second drug. The same ratio is established in the second ten codes to the sixth ten codes. (Permuted Block Randomization) ABBAABABAB, BBAABABAAB, ABABBAABBA, AABABABABB, AAABABBBAB, BABABAABBA This type of design provides the conditions for intermediate tests, So that after the execution of each complete block, statistical tests can be performed, and if the result is reached and the difference between the two groups is significant, and the test power is maintained, the study can be stopped, Blinding description: Sumac-cloxacillin gel and placebo gel both have the same color, smell and appearance and are poured into the same tubes. Each tube is assigned a code consisting of numbers and letters. These codes are distributed based on a table of random numbers between the drug and placebo groups and the researcher and the patient are not aware of it. 2-3 Condition 1: Diabetic foot ulcer caused by type 1 diabetes. Condition 2: Diabetic foot ulcer caused by type 2 diabetes. Intervention 1: Intervention group: Both groups (intervention and control) receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitalization (if necessary), and off-loading procedures. The intervention group receives a gel containing Sumac extract and Cloxacillin. The interventions are twice a day and will last for 8 weeks. Intervention 2: Control group: Both groups (intervention and control) receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitalization (if necessary), and off-loading procedures. The control group receives placebo gel. Placebo gel contains gelling agent, water and preservative and does not contain Sumac extract and Cloxacillin. The interventions are twice a day and will last for 8 weeks. Yes - There is a plan to make this available What will be shared: In the case of patient data, only a portion of the data, such as information about the main outcome or the like, can be shared. The documents to be published will be published in the article. The general consent form is available at the University Vice Chancellor for Research. When: Start the access period: After publishing the article To whom: Researchers working in academic and scientific institutes, people working in industry Conditions: Copying is prohibited. It is mandatory to follow the principles of referral. Where to obtain: The applicant for the article can submit his request to the person in charge of updating the information or read the article in the published journal. Responsible for updating information: Fatemeh Azadi Contact number: 09124125372 Email: fazadi1998@gmail.com How to obtain: The applicant can notify the applicant of the article by email or call, and the article will be emailed to the applicant within five days of the request. Comments:
public Mohammad Mahdi Ahmadian-Attari
School of Pharmacy, Next to Imam Ali Hospital, Valiasr Street, Shora Blvd.
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 ahmadian.attari@gmail.com Karaj University of Medical Sciences scientific Meysam Shirzad
School of Traditional Medicine, Sarparast St., Taleqani St., Felestin Square, Tehran
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4535 shirzadmd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with type 1 or 2 Diabetes Age 30 years or older Grade 1 and 2 diabetic ulcers according to Wagner classification system Adherence to routine diabetes treatments Ankle Brachial Index (ABI) greater than 0.7 30 years no limit Both Pregnancy or Breastfeeding Presence of infection in the wound before admission Presence of neoplasia Use of immunosuppressive drugs E10.51 E11.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene Treatment - Drugs Placebo Intervention group: Both groups (intervention and control) receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitalization (if necessary), and off-loading procedures. The intervention group receives a gel containing Sumac extract and Cloxacillin. The interventions are twice a day and will last for 8 weeks. Control group: Both groups (intervention and control) receive routine treatment including debridement, infection control and treatment (if the wound becomes infected), hospitalization (if necessary), and off-loading procedures. The control group receives placebo gel. Placebo gel contains gelling agent, water and preservative and does not contain Sumac extract and Cloxacillin. The interventions are twice a day and will last for 8 weeks. Wound area and dimensions. Timepoint: Weekly for 8 weeks. Method of measurement: Photography of ulcers and Computer software. Presence or absence of infection in the wound. Timepoint: Weekly for 8 weeks. Method of measurement: Wound examination and Visual observation. Incidence of side effects. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Asking the patient and Examining the wound by the visitor (symptoms such as burning, itching, redness, etc. while using the gel). Tolerability. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Ask the patient if there is any discomfort while taking the drug or If there is any factor that makes the patient reluctant to continue treatment and the cause is related to the gel used. Pain assessment. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: The patient scores from one to ten, depending on the amount of pain he feels.(Visual Analogue Scale). Quality of life score. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: Questionnaire for quality of life of patients with diabetic foot ulcers.(Designed by Johnson in the UK, 1995). Karaj University of Medical Sciences Approved 2022-03-06 Ethics committee of Alborz University of Medical Sciences Deputy of research and technology, Saffarian Alley, Golshahr Ave. karaj Alborz Iran (Islamic Republic of)