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IRCT20250728066662N1 IRCT 2025-09-01 Ghoum University of Medical Sciences Evaluation of Havachobe ointment effect in healing diabetic foot ulcers Evaluation of Arnebia euchroma ointment effect in healing diabetic foot ulcers compared to simple dressings 2025-08-23 anticipated 60 Complete https://irct.ir/trial/85138 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be performed using blocks of 4. So that all possible sequences of two drug and two placebo in each block will be made with each block being numbered. Then, using random number table, the blocks will be selected randomly and the patients will be assigned to the two groups of drug and placebo according to the the blocks sequences. 3 Diabetic foot ulcer. Intervention 1: Intervention group: Abu Khalsa ointment was applied in the amount necessary to create a 3 mm thick layer on sterile gauze and placed on the wound surface. Intervention 2: Control group: Only simple dressings are used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Monireh Seraj
No. 19, Hasht Behesht Ave., Valiasr Blvd.
Najafabad Iran (Islamic Republic of) 8517770006 +98 31 4274 7977 dr.seraj.1400@gmail.com Ghoum University of Medical Sciences scientific Monireh Seraj
No. 19, West Hashtbehesht Ave., Valiasr Blvd., Najafabad Town
Najafabad Iran (Islamic Republic of) 8517770006 +98 31 4274 7977 Dr.seraj.1400@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Having a grade 2 diabetic foot ulcer in one or more areas no limit no limit Both -Currently smoking Taking anticoagulant medication in the last 3 months Taking immunosuppressive medication in the last 3 months Having a coagulation disorder such as hemophilia Taking medications or supplements containing vitamin C, A or ZINK in the last 3 months Having chronic vascular insufficiency with a cause other than diabetes Hb A1C more than 10 No taking broad-spectrum oral antibiotics during this period of wound treatment Abscess or swelling in the wound area Treatment - Drugs Treatment - Devices Intervention group: Abu Khalsa ointment was applied in the amount necessary to create a 3 mm thick layer on sterile gauze and placed on the wound surface. Control group: Only simple dressings are used Wound size. Timepoint: Before the start of the aforementioned interventions, the wound size is determined and recorded as the product of the largest length and the largest width of the wound in centimeters, as well as the presence or absence of erythema (redness) around the wound. At the end of days 10 and 21 (end of the intervention), the wound size is determined and recorded again. Method of measurement: Ruler. Number of cases of erythema. Timepoint: Before the start of the aforementioned interventions, the wound size is determined and recorded as the product of the largest length and the largest width of the wound in centimeters, as well as the presence or absence of erythema (redness) around the wound. At the end of days 10 and 21 (end of the intervention), the wound size is determined and recorded again. Method of measurement: Observation and photography. Ghoum University of Medical Sciences Approved 2025-07-27 Ethics Committee of Qom University of Medical Sciences Shahid Lavasani Street, Qom University of Medical Sciences Qom Ghoum Iran (Islamic Republic of)