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IRCT20250610066159N1 IRCT 2025-10-12 Pajoohesh BAMA Co Investigation of the Effects of Lemon Balm (Melissa officinalis) on Diabetic Wounds SNWD-DM Smart Nano-Wound Dressing for Wound Healing in Diabetic Patients: A Randomized Controlled Trial 2025-11-21 anticipated 60 Recruiting https://irct.ir/trial/84449 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were assigned to the treatment and control groups using block randomization (block size = 4) generated with R software. The randomization sequence was prepared and coded by a researcher not involved in the study execution. The trial was conducted in a double-blind manner, so that both participants and outcome assessors were unaware of group allocation. This study was designed as a multicenter, controlled, randomized clinical trial, Blinding description: A stratified randomization method will be used. Patients will be divided into two groups based on the presence of diabetic wounds and whether they will receive the specialized dressing (intervention) or the standard dressing (control). Randomization within each group will then be performed using a pre-prepared randomization list. This list will be generated by the physician prior to the study. The principal investigator will introduce the selected patients to the clinical caregiver and the outcome assessor (a nursing specialist) responsible for the process. According to the list, wound treatment will be carried out using either the nano-wound dressing or the standard wound dressing. N/A Diabetic wound. Intervention 1: Smart nanofiber wound dressing containing 1% Melissa officinalis extract:Patients in the intervention group will use a smart nanofiber wound dressing containing 1% Melissa officinalis extract, produced by the company “Pajohesh Ba Ma”. The dressing will be changed every 6 days by a trained nurse. The total treatment duration is two weeks. During each dressing session, patients will receive the necessary training on wound care. Additional materials include bandage and adhesive tape. Intervention 2: Control group: Standard wound dressing: https://chatgpt.com/c/68eb66d9-7538-832e-bb06-9d1e7e28e660#:~:text=Patients%20in%20the%20control%20group%20will%20use%20standard%20wound%20dressing.%20The%20dressing%20will%20be%20changed%20every%206%20days%20according%20to%20standard%20clinical%20guidelines.%20The%20total%20treatment%20duration%20is%20two%20weeks%2C%20and%20all%20patients%20will%20receive%20wound%20care%20education%20from%20a%20trained%20nurse. Yes - There is a plan to make this available What will be shared: Production of smart nanowound dressings in wound healing in diabetic patients: A randomized clinical trial When: 1 year after the end of the clinical study To whom: Medical researchers Conditions: For future studies in the field of wound healing and with permission from the project manager Where to obtain: Permission must be obtained in writing from the project manager. How to obtain: 1- Request access to the project implementer 2- Review by the implementer and the partner team 3- Approval of the request by the implementer 4- Permission to access the data Comments:
public Dr. Ghazaleh Chizari Fard
Unit 9, No. 42, Maleki Street, Golbarg Sharghi, Bagheri Highway, Tehranpars, Tehran, Iran
Tehran Iran (Islamic Republic of) 1651897463 +98 21 7772 7495 chizarigh@gmail.com Pajooshesh BAMA Co. scientific Dr. Ghazaleh Chizari Fard
No. 42, Maleki Street, East Golbarg, Bagheri Highway, Tehranpars.
Tehran Iran (Islamic Republic of) 1651897463 +98 21 7772 7495 chizarigh@gmail.com Pajoohesh BAMA Co. Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with diabetic wounds Participants aged between 18 and 80 years Participants who demonstrate adequate compliance with the use of the wound dressing throughout the treatment period Participants who have provided written informed consent prior to enrollment 18 years 80 years Both Not applicable E11.622 Type 2 diabetes mellitus with other skin ulcer Treatment - Devices Treatment - Devices Smart nanofiber wound dressing containing 1% Melissa officinalis extract:Patients in the intervention group will use a smart nanofiber wound dressing containing 1% Melissa officinalis extract, produced by the company “Pajohesh Ba Ma”. The dressing will be changed every 6 days by a trained nurse. The total treatment duration is two weeks. During each dressing session, patients will receive the necessary training on wound care. Additional materials include bandage and adhesive tape. Control group: Standard wound dressing: https://chatgpt.com/c/68eb66d9-7538-832e-bb06-9d1e7e28e660#:~:text=Patients%20in%20the%20control%20group%20will%20use%20standard%20wound%20dressing.%20The%20dressing%20will%20be%20changed%20every%206%20days%20according%20to%20standard%20clinical%20guidelines.%20The%20total%20treatment%20duration%20is%20two%20weeks%2C%20and%20all%20patients%20will%20receive%20wound%20care%20education%20from%20a%20trained%20nurse. The primary outcome variable is wound healing, measured as the reduction in wound area in patients treated with the smart nano-wound dressing. Wound area will be assessed using graph paper measurement or digital imaging software at specified time points. Changes in wound area between the treatment and control groups will be compared as the main indicator of study efficacy. Timepoint: Assessments will be conducted on days 0, 7, 14, and 28, with the schedule extended as needed until complete wound healing. Method of measurement: Wound evaluation will be performed through visual inspection and by measuring the wound surface area. Pajoohesh BAMA Co Approved 2025-05-18 ethics committee of Bam University of Medical Science Shahid Rajaei Boulevard, Sardarān-e Shahid Square, Bam, Iran Bam Kerman Iran (Islamic Republic of)