Protocol summary
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Study aim
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Investigating the benefits of using bacterial nanocellulose dressing in the healing of diabetic foot ulcers.
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Design
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Controlled clinical trial with parallel groups, without blinding, randomized, phase 3 on 36 patients. Lottery of sealed envelopes will be used for randomization.
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Settings and conduct
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This trial will be conducted in a single center and in Imam Ali Karaj Hospital. The number of 36 patients who meet the necessary criteria to will be included in the study and randomly and by lottery will be placed in one of the groups of standard treatment or treatment with nanocellulose dressing. The time to full healing, the average percentage of wound healing will be measured in weekly visits and patient satisfaction at the end of the treatment. Finally, all these cases will be compared between the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criterion is a non-infectious lower extremity wound with an ABI (ankle/brachial index) of four or more. Patients with osteomyelitis, heart failure, patients undergoing chemotherapy, dialysis and Wagner grade IV or V will be excluded.
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Intervention groups
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The intervention group includes patients with diabetic foot ulcers who receive standard treatment intervention with the use of bacterial nanocellulose coating. The control group includes patients with diabetic foot ulcers who receive only the standard treatment.
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Main outcome variables
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Time to full healing, average percentage of wound healing in weekly visits and patient satisfaction
General information
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Reason for update
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Considering that BNC dressing was used for infected wounds in several cases and the results were satisfactory, we decided to include people with infected diabetic foot ulcers in the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160117026069N7
Registration date:
2023-02-11, 1401/11/22
Registration timing:
prospective
Last update:
2024-05-13, 1403/02/24
Update count:
1
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Registration date
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2023-02-11, 1401/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-11-22, 1402/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of nanocellulose wound dressing with standard treatment in diabetic foot ulcer healing: a randomized controlled clinical trial
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Public title
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Nanocellulose dressing for diabetic foot ulcer healing
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
A lower limb ulcer with an ABI (ankle/brachial index) of four or more
Exclusion criteria:
Osteomyelitis
Heart failure
Patients undergoing chemotherapy
Patients undergoing dialysis
Wagner grade IV or V
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-22, 1401/11/02
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Ethics committee reference number
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IR.ABZUMS.REC.1401.282
Health conditions studied
1
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Description of health condition studied
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Diabetic foot ulcer
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ICD-10 code
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Z86.31
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ICD-10 code description
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Personal history of diabetic foot ulcer
Primary outcomes
1
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Description
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Time to full healing
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Timepoint
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The last weekly visit of the patient
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Method of measurement
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The examination of the physician
2
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Description
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Average percentage of wound healing (relative to initial wound size) in weekly visits
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Timepoint
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Weekly to the end of the treatment
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Method of measurement
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Comparison of the size of the wound with the initial size by photographing next to the ruler
3
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Description
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Patient satisfaction
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Timepoint
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The last visit of the patient
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Method of measurement
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Asking from the patient
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Karaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Access starts 6 months after results are published
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To whom data/document is available
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All researchers working in academic and scientific institutions and people working in the industry
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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From the project manager, Dr. Hadi Pourjafar
pourjafarhadi59@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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