This study aims to evaluate the efficacy of a synthesized nano-wound dressing in the treatment of diabetic wounds
Design
Study Procedure:
Test Group:
The surrounding area of the wound will be disinfected and cleaned (standard wound washing and controlled debridement).
The nano-wound dressing will be applied to the wound, ensuring maximum contact with the wound surface.
A suitable secondary dressing will be placed over the nano-wound dressing.
The dressing will be changed every 2 to 3 days.
The patient will be kept at room temperature to avoid direct sunlight exposure.
Control Group:
Standard wound dressings (gauze, foam, or hydrogel) will be used.
Dressings will be changed every 2 to 3 days.
All other wound care procedures will be the same as in the test group.
Data Analysis:
At the end of each stage, outcome evaluation and statistical analysis will be performed.
Settings and conduct
The study will be carried out as a double-blind, multicenter trial at institutions affiliated with Iran University of Medical Sciences and Bam University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18–80 years with diabetic wounds of varying grades and sizes between 1–15 cm², who have provided written informed consent for follow-up and demonstrate compliance with the use of the nano-wound dressing.
Exclusion criteria: Participants who do not meet any of the above requirements or fail to comply during the study.
Intervention groups
Intervention group: Patients with diabetic wounds treated with the nano-wound dressing alongside standard wound care.
Control group: Patients with diabetic wounds treated with the standard wound dressing alongside standard wound care.
Main outcome variables
Primary outcomes: Wound closure rate and wound healing duration.
General information
Reason for update
Acronym
SNWD-DM
IRCT registration information
IRCT registration number:IRCT20250610066159N1
Registration date:2025-10-12, 1404/07/20
Registration timing:prospective
Last update:2025-10-12, 1404/07/20
Update count:0
Registration date
2025-10-12, 1404/07/20
Registrant information
Name
Ghazaleh Chizarifard
Name of organization / entity
Bam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7772 7495
Email address
chizarigh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-21, 1404/08/30
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Smart Nano-Wound Dressing for Wound Healing in Diabetic Patients: A Randomized Controlled Trial
Public title
Investigation of the Effects of Lemon Balm (Melissa officinalis) on Diabetic Wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Not applicable
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Bam University of Medical Science
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
No. 42, Maleki Street, East Golbarg, Bagheri Highway, Tehranpars.
City
Tehran
Province
Tehran
Postal code
1651897463
Phone
+98 21 7772 7495
Email
chizarigh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pajoohesh BAMA Co.
Full name of responsible person
Dr. Ghazaleh Chizari Fard
Position
CEO
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 42, Maleki Street, East Golbarg, Bagheri Highway, Tehranpars.
City
Tehran
Province
Tehran
Postal code
1651897463
Phone
77727495
Email
chizarigh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Production of smart nanowound dressings in wound healing in diabetic patients: A randomized clinical trial
When the data will become available and for how long
1 year after the end of the clinical study
To whom data/document is available
Medical researchers
Under which criteria data/document could be used
For future studies in the field of wound healing and with permission from the project manager
From where data/document is obtainable
Permission must be obtained in writing from the project manager.
What processes are involved for a request to access data/document
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