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IRCT20180523039810N1 IRCT 2018-07-08 Mashhad University of Medical Sciences Evaluation of efficacy of topical application of ring worm extract in the treatment of diabetic foot Evaluation of efficacy and safety of topical application of ring worm extract (eisenia foetida) in the treatment of diabetic foot 2018-01-10 anticipated 20 Complete https://irct.ir/trial/31503 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two groups of intervention and control using simple randomization method. N/A Diabetic foot ulcer. Intervention 1: Control group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin for every 12 hours are prescribed. Wound washing with normal sterile saline, use of Vaseline on the wound and dressing change twice a day, and control of fasting blood sugar are carried out daily. Intervention 2: Intervention group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin fore every 12 hours are prescribed. After daily wound washing with normal sterile saline, the topical eisenia foetida extract is used under the dressing. The dressing is changed twice a day, and Fasting blood sugar control is carried out daily. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable When: Data can be accessible 6 months after results are published To whom: All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures. Conditions: In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed. Where to obtain: Through sending an email to the corresponding author, data will be obtainable. How to obtain: In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months Comments:
public Bita Kiafar
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3858 3845 kiafarb@mums.ac.ir Mashhad University of Medical Sciences scientific Bita Kiafar
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3858 3845 kiafarb@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Type 2 Diabetes Mellitus for at least 5 years Age between 30 to 65 years Body Mass Index (BMI) between 18 and 35 Wagner grade of 1 and 2 30 years 65 years Both Lack of patient's follow-up Patient dissatisfaction at each stage of the study Complications caused by treatments during study Creation of acute or severe complications of diabetes due to exacerbation of underlying illness Having other systemic diseases that may affect the ulcer Use of tobacco, alcohol, narcotics, cytotoxic drugs and glucocorticoid and immunosuppressive drugs. Pregnancy and breast feeding Wagner grade of 3 to 5 HbA1C hemoglobin level of more than 10 E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Control group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin for every 12 hours are prescribed. Wound washing with normal sterile saline, use of Vaseline on the wound and dressing change twice a day, and control of fasting blood sugar are carried out daily. Intervention group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin fore every 12 hours are prescribed. After daily wound washing with normal sterile saline, the topical eisenia foetida extract is used under the dressing. The dressing is changed twice a day, and Fasting blood sugar control is carried out daily Rate of patient's wound size improvement. Timepoint: At the beginning of the treatment and monthly follow up until 3 months after first ointment use. Method of measurement: The percentage of recovery is calculated as a percentage of wound size reduction (measured on a millimeter basis) including length-width-depth (by sterile swab) per visit. Mashhad University of Medical Sciences Approved 2018-01-10 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)