FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/068228 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to assess the effectiveness of 2 dressings in managing the diabetic foot wounds  
Scientific Title of Study   A study comparing the efficacy of tertiary ammonium compound based foam dressing versus silver based foam dressing in non ischemic diabetic foot ulcer patients using wound ischemia foot infection grading WIFI GRADE 2 in a tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahala Shirin T P  
Designation  Junior Resident 
Affiliation  Government medical college Kozhikode 
Address  Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode

Kozhikode
KERALA
673008
India 
Phone  8075498461  
Fax    
Email  shahalashirintp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chandrasekharan S 
Designation  Associate professor 
Affiliation  Government medical college Kozhikode 
Address  Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9446394276  
Fax    
Email  sekhardr@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Chandrasekharan S 
Designation  Associate professor 
Affiliation  Government medical college Kozhikode 
Address  Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9446394276  
Fax    
Email  sekhardr@yahoo.co.in  
 
Source of Monetary or Material Support  
Government medical college Medical College Junction, Mavoor Rd, Kozhikode, Kerala 673008 
 
Primary Sponsor  
Name  Shahala Shirin T P 
Address  Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shahala Shirin T P  Government medical college Kozhikode  Department of general surgery Government medical college Medical College Junction, Mavoor Rd, Kozhikode
Kozhikode
KERALA 
8075498461

shahalashirintp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Medical College Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L979||Non-pressure chronic ulcer of unspecified part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Silver based foam dressing  Combination of inorganic silver and dressing Will be applied every week for 6 months or until complete healing 
Intervention  Tertiary ammonium compound based 3D hydrocellular dressing  Consists of Tertiary ammonium compound (DTAC) for antimicrobial action and a 3-D Knitted Hydrocellular textile substrate made of Polyethylene Terephthalate (PET) and Polyurethane (PU) Will be applied every week for 6 months or until complete healing 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Grade 2 diabetic foot ulcer satisfying WIFi classification
2. Willing to give written informed
consent for the study 
 
ExclusionCriteria 
Details  1. Diabetic foot ulcers with underlying ischemia, neuropathy
2. All causes of foot ulcer, which can be attributed to other coexisting diseases like paraplegia, varicose vein, etc.
3. Patient with known hypersensitivity to ammonium or ionic silver
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time duration needed for complete wound healing  Weekly until complete healing or 6 months post dressing 
 
Secondary Outcome  
Outcome  TimePoints 
Number of debridement and dressings needed  Weekly until complete healing or 6 months post dressing 
Cost efficacy   After complete healing or 6 months  
Presence of slough as percentage of total ulcer surface area  Weekly until complete healing or 6 months post dressing 
Presence of granulation as percentage of total ulcer surface area  Weekly until complete healing or 6 months post dressing 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

There are multiple factors associated with the development of diabetic foot ulcer , such as the complex process and complications of diabetes, may all lead to various degrees of neurological abnormalities and vascular damage. once the ulcer is formed, the factors affecting healing may be more complex, and different factors may dominate at different stages over time. thus, these related factors play different roles depending on the severity of disease and duration of recovery, necessitating different diagnoses and treatments for seemingly the same symptoms and causing differences in the curative effect. in these circumstances, the classification and scoring criteria for describing lesions of diabetic foot                           ulcer should be formatted in a manner that is clinically recognized and widely used, which will allow characterization of diabetic foot ulcer on the basis of differences and facilitate suggestions for treatment or care programs.

Silver based foam dressings can continuously and effectively release silver ions, kill the wound and surrounding bacteria, improve the wound healing environment, and can also hydrate and soften necrotic tissue and clean the wound. silver ions can bind to negatively charged bacteria, enhance the permeability of the bacterial outer membrane, and induce bacterial apoptosis. the silver dressing has a certain toxic effect on fibroblasts of diabetic patients, which can reduce its cell activity and collagen synthesis, and significantly change cell morphology. some studies have found that silver dressings significantly reduce odour, improve pain-related symptoms, decrease wound exudate, and have a prolonged dressing wear time.

Recently, dimethyl tetradecyl ammonium chloride (DTAC) based 3d-hydrocellular wound dressings have emerged. DTAC is a cationic surfactant used at the concentration of 1% w/w,  based on DTAC technology, 3d-hydrocellular wound dressing is formulated as a 3- dimensional knitted fabric. The 3-dimensional knitted fabric comprises of DTAC-bounded polyethylene terephthalate (90% w/w) and polyurethane material (10% w/w), forming a 3D hydrocellular structure. DTAC-based dressing acts as a physical barrier against contaminants, helps in gaseous exchange, maintains the moist environment, and manages the exudates effectively. They are primarily used for exuding, minor, chronic and surgical wounds, and first and second-degree burns. The exceptional properties of DTAC technology are the “physical kill mechanism” for microbial protection and the non-leachability of DTAC into the skin or out  of the dressing. The cross-linking property ensures that the active component remains bounded to the surface of the dressing. in addition, the DTAC dressings as antimicrobial, cover a broad spectrum of microbes and eradicate the infection load at the wound site

 
Close