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IRCT20221015056180N1 IRCT 2022-11-02 Rasht University of Medical Sciences effect of potassium permanganate solution on diabetic foot Evaluation of the effect of topical potassium permanganate 5% solution on foot ulcers in diabetic patients – a randomisad controled clinical trial 2022-11-06 anticipated 22 Complete https://irct.ir/trial/66315 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Type of randomization: in this research, in order to allocate patients to intervention and control groups, a resticted randomization approach will be used in a parallel way and random allocation rule. To generate random numbers, online randomization will be used at the following address http://www.graphpad.com/quickcalcs/index.cfm Allocation concealment method: Random allocation concealment method will be used for concealment. At the time of registration of eligible patients for the study, using identical sealed envelopes with random sequence, the patient will be a candidate to receive one of two types of treatment. N/A Diabetes. Intervention 1: Intervention group: Patients in the intervention group will wash the wound with soap and water every day and then use potassium permanganate 5% solution topically. This solution is bought by the researcher from the pharmacy. And every week, the patient will be given the necessary amount to consume for a week. To prepare a solution of potassium permanganate 5%, the pharmacist combines 5 grams of it with 100 cc of distilled water. (This will be done under standard conditions and by the pharmacist). Patients are instructed to apply the solution with cotton soaked in potassium permanganate to all parts of their diabetic foot ulcer, so that the whole ulcer is covered with the solution and the healthy parts of the skin are not covered with the solution and not to wash the wound with water after that. Intervention 2: Control group: The control group is a candidate to receive the standard treatment of diabetic foot ulcer. The standard treatment of diabetic foot ulcer is as follows: removal and transfer of pressure from the area of diabetic foot ulcer, daily washing of the ulcer with mild soap and water, checking the condition of the ulcer daily. 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 six 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: Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran Address: Burn Research Center and Regenerative Medicine, Velayat Hospital (3rd floor), Namjo St., Rasht. Contact phone: +98-1333368540 Dr. Mohammad Reza Mobayen Email address: Mmobayen@gums.ac.ir How to obtain: Researchers should send a written request to receive data to the relevant email address. The review of the documents and the application is done within two to four weeks. Then, if the necessary conditions are met, the data will be provided to the researchers by the research center. Comments:
public Dr Afrooz Haghdoost
Burn and Regenerative Medicine Research center, Khanali Zade St, Namjoo St, Velayat hospital,
Rasht Iran (Islamic Republic of) 4193713191 00931333368540 haghdoost.afrooz@yahoo.com Rasht University of Medical Sciences scientific Dr Afrooz Haghdoost
Burn and Regenerative Medicine Research center, Khanali Zade St, Namjoo St, Velayat hospital,
Rasht Iran (Islamic Republic of) 4193713191 +98 13 3336 8540 haghdoost.afrooz@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Outpatient referral Patients with type 2 diabetes Diabetic foot ulcer with Wagner score 1 or 2 Presence of chronic neuropathic and non-ischemic diabetic foot ulcer that has been present for at least 3 months Patients in the age range of 18 to 65 years 18 years 65 years Both The presence of ischemia symptoms in the lower limbs and ankle-brachial index and toe-brachial index (ABI, TBI) less than 0.7 Advanced wound infection ICDE-10 ﻣﺮﺑﻮط ﺑﻪ ﻋﻮارض ﻧﻮروﻟﻮژﻳﻚ و ﺳﺎﻳﺮ ﻋﻮارض دﻳﺎﺑﺖ Treatment - Drugs Other Intervention group: Patients in the intervention group will wash the wound with soap and water every day and then use potassium permanganate 5% solution topically. This solution is bought by the researcher from the pharmacy. And every week, the patient will be given the necessary amount to consume for a week. To prepare a solution of potassium permanganate 5%, the pharmacist combines 5 grams of it with 100 cc of distilled water. (This will be done under standard conditions and by the pharmacist). Patients are instructed to apply the solution with cotton soaked in potassium permanganate to all parts of their diabetic foot ulcer, so that the whole ulcer is covered with the solution and the healthy parts of the skin are not covered with the solution and not to wash the wound with water after that. Control group: The control group is a candidate to receive the standard treatment of diabetic foot ulcer. The standard treatment of diabetic foot ulcer is as follows: removal and transfer of pressure from the area of diabetic foot ulcer, daily washing of the ulcer with mild soap and water, checking the condition of the ulcer daily. Local infection of diabetic foot ulcer. Timepoint: Investigation of wound infection at the beginning of the study and then on days 7, 14 and 21. Method of measurement: Based on the examination and determining the Wagner score of diabetic foot ulcer. Size of diabetic foot ulcer. Timepoint: Measurement of diabetic foot ulcer at the beginning of the study and then on days 7, 14 and 21. Method of measurement: With examination and caliper device. Granulation tissue formation. Timepoint: Examination of granulation tissue formation at the beginning of the study and then on days 7, 14 and 21. Method of measurement: Based on examination 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 and 21. Method of measurement: Based on the examination of the attending physician. Rasht University of Medical Sciences Approved 2022-08-17 Ethics committee of Guilan University of Medical Sciences Deputy of research and technology of Guilan university of medical sciences, Siyadati St, Namju St Rasht Guilan Iran (Islamic Republic of)