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IRCT20221031056351N1 IRCT 2022-11-21 Kermanshah University of Medical Sciences Investigation of the effectiveness and usefulness of topical gel containing pomegranate husk extract in the healing of diabetic foot ulcers Investigation of potentially effectiveness of pomegranate husk extract topical gel on wound healing of diabetic foot ulcers: A randomized, parallel controlled phase II clinical trial 2022-12-22 anticipated 40 Complete https://irct.ir/trial/66692 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by the random block method with a block size of 4. Unlike simple randomization, in which eligible patients are randomly assigned directly to treatments, in randomization with random blocks, patients are randomly assigned to the blocks in a sequence according to the size of the blocks, and finally, in each block of size 4, two patients will be randomly assigned to each intervention. Considering that the size of the blocks is assumed to be 4, there are six random arrangements or modes for the same allocation of patients to two interventions in each block, and this random sequence for the random allocation of patients to interventions in the block will be created by the methodology consultant. The rest of the project colleagues do not have access to the details of the random sequence until after the random allocation of patients, Blinding description: The blinding will be unilateral, so that the evaluator who will follow the patient will be blinded to the type of intervention. 2 Condition 1: Diabetic foot ulcer caused by type 1 diabetes. Condition 2: Diabetic foot ulcer caused by type 2 diabetes. Intervention 1: Control group: The usual wound care from the second day includes washing twice a day with water without betadine along with debridement if needed. Intervention 2: Intervention group: In addition to the mentioned cases, a topical gel containing pomegranate fruit husk extract (2.5%) is used topically daily, and routine care is also performed. No - There is not a plan to make this available Justification or reason for not sharing IPD is After patent registering of the study, it will be acted.
public Hamidreza Mohammadimotlagh
Medical Biology Research Center, Nurse Boulevard, Sorkheh Lizheh
Kermanshah Iran (Islamic Republic of) 6714415185 +98 83 3427 6473 hamidreza.mohammadimotlagh@kums.ac.ir Kermanshah University of Medical Sciences scientific Mohammad Bagher Heydari
Imam Reza Hospital, next to Medical School, Nurse Boulevard, Sorkheh Lizheh
Kermanshah Iran (Islamic Republic of) 6742775333 +98 83 3427 6300 mohammadbagher_heydari@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diabetic patients with ulcers in the lower limbs who have not had more than a 50% reduction in the size of their ulcer during the last month. no limit no limit Both Evidence of bone and tendon, an abscess with local erythema and tenderness at the wound site, osteomyelitis, malignancy, use of anti-inflammatory drugs and growth factors in the last 2 weeks and radiotherapy in the last three months, and lack of consent to participate in the study. 10.5 11.5 Type 1 diabetes mellitus with peripheral circulatory complications Type 2 diabetes mellitus with peripheral circulatory complications Treatment - Drugs Treatment - Drugs Control group: The usual wound care from the second day includes washing twice a day with water without betadine along with debridement if needed. Intervention group: In addition to the mentioned cases, a topical gel containing pomegranate fruit husk extract (2.5%) is used topically daily, and routine care is also performed. Duration of complete wound healing (initial). Timepoint: at different times of 7, 14, 21 and 30 days. Method of measurement: Based on the diabetic foot ulcer assessment checklist. Wound area before intervention and after intervention on days 7, 14, 21, and 30 (secondary). Timepoint: at different times of 7, 14, 21 and 30 days. Method of measurement: Based on the diabetic foot ulcer assessment checklist. Zist Tolid Razi Company Approved 2022-06-21 Kermanshah University of Medical Sciences (Research Ethics Committee) No. 2 Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Street Kermanshah Kermanshah Iran (Islamic Republic of)