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IRCT20160117026069N7 IRCT 2023-02-11 Karaj University of Medical Sciences Nanocellulose dressing for diabetic foot ulcer healing Comparison of nanocellulose wound dressing with standard treatment in diabetic foot ulcer healing: a randomized controlled clinical trial 2023-02-20 anticipated 36 Complete https://irct.ir/trial/68198 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes. 3 Diabetic foot ulcer. Intervention 1: Intervention group: The standard treatment method includes debridement, removing pressure from the leg with plaster or other tools, or using a dry pressure bandage, which will be done in this group. If necessary, debridement will be done with sharp surgical instruments and then the wound area will be washed with physiological serum. In this group, the nanocellulose coating made by the research team will be selected with the appropriate size of the wound, and the wrinkles on its surface will be smoothed using moist gauze with saline. According to the available evidence, a single nanocellulose coating is sufficient for complete wound healing, but this coating will be replaced if needed. Wound decompression devices or dry pressure bandages will also be applied weekly to all wounds. Intervention 2: Control group: The standard treatment method includes debridement, removing pressure from the leg with plaster or other tools, or using a dry pressure bandage, which will be done in this group. If necessary, debridement will be done with sharp surgical instruments and then the wound area will be washed with physiological serum. In this group, in every visit, the wound will be washed and bandaged using the usual dressing. Wound decompression devices or dry pressure bandages will be applied weekly to all wounds. Yes - There is a plan to make this available What will be shared: All non-identifiable personal data of participants, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in analysis, and data dictionary will be shared after the end of the study. When: Access starts 6 months after results are published To whom: All researchers working in academic and scientific institutions and people working in the industry Conditions: The data can be analyzed and used within the framework of the study protocol, but the right to publish the data will be with the research team, and if the data is published by other people, it is necessary to mention the source. People who wish to have access to data or documents should send their written request to Dr. Hadi Pourjafar's email and explain their reason for needing these data or documents and how they will use them. If a request with this theme is received, a decision will be made with the opinion of the research team and taking into account the job title of the applicant and the content of the written request sent by him. Where to obtain: From the project manager, Dr. Hadi Pourjafar pourjafarhadi59@gmail.com How to obtain: The applicant must first submit a request including the requested data or document, the reason for the need for this data or document and the uses he will make of it along with a brief introduction of himself and his company or university to Mr. Hadi Pourjafar. After submitting the application to the project manager, this application will be reviewed at the earliest opportunity and within two weeks after receiving the application in a meeting with the presence of all those involved in the project. will be provided to the applicant. Comments:
public Hadi Pourjafar
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 pourjafarhadi59@gmail.com Karaj University of Medical Sciences scientific Reyhaneh Mahmoodian
Imam Ali Medical Education and Treatment Center, Vali-asr Blvd., Esteghlal Blvd., Esteghlal Sq.
Karaj Iran (Islamic Republic of) 3154686695 +98 26 3447 8835 reyhanehmahmoodian@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) A lower limb ulcer with an ABI (ankle/brachial index) of four or more no limit no limit Both Osteomyelitis Heart failure Patients undergoing chemotherapy Patients undergoing dialysis Wagner grade IV or V Z86.31 Personal history of diabetic foot ulcer Treatment - Other Treatment - Other Intervention group: The standard treatment method includes debridement, removing pressure from the leg with plaster or other tools, or using a dry pressure bandage, which will be done in this group. If necessary, debridement will be done with sharp surgical instruments and then the wound area will be washed with physiological serum. In this group, the nanocellulose coating made by the research team will be selected with the appropriate size of the wound, and the wrinkles on its surface will be smoothed using moist gauze with saline. According to the available evidence, a single nanocellulose coating is sufficient for complete wound healing, but this coating will be replaced if needed. Wound decompression devices or dry pressure bandages will also be applied weekly to all wounds. Control group: The standard treatment method includes debridement, removing pressure from the leg with plaster or other tools, or using a dry pressure bandage, which will be done in this group. If necessary, debridement will be done with sharp surgical instruments and then the wound area will be washed with physiological serum. In this group, in every visit, the wound will be washed and bandaged using the usual dressing. Wound decompression devices or dry pressure bandages will be applied weekly to all wounds. Time to full healing. Timepoint: The last weekly visit of the patient. Method of measurement: The examination of the physician. Average percentage of wound healing (relative to initial wound size) in weekly visits. Timepoint: Weekly to the end of the treatment. Method of measurement: Comparison of the size of the wound with the initial size by photographing next to the ruler. Patient satisfaction. Timepoint: The last visit of the patient. Method of measurement: Asking from the patient. Karaj University of Medical Sciences Approved 2023-01-22 Ethics committee of Alborz University of Medical Sciences Saffarian Alley, Golshahr Blvd, Karaj Karaj Alborz Iran (Islamic Republic of)