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CTRI Number  CTRI/2024/04/065881 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 02/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see if Nanocrystalline silver dressings are better than conventional dressings in treating diabetic foot ulcer patients 
Scientific Title of Study   Comparative study between Nanocrystalline silver dressing versus conventional dressings in Diabetic foot ulcers - A randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Ramkamal balachandran  
Designation  Post graduate MS General surgery 
Affiliation  Sri manakula Vinayagar medical college and hospital,Puducherry 
Address  Department of general surgery, Sri manakula vinayagar medical college and hospital

Pondicherry
PONDICHERRY
605008
India 
Phone  7200484925  
Fax    
Email  ramkmlbala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gv Manoharan 
Designation  Professor and Head of Department 
Affiliation  Sri manakula Vinayagar medical college and hospital 
Address  Department of general surgery Sri manakula Vinayagar medical college and hospital

Pondicherry
PONDICHERRY
605107
India 
Phone  9443112296  
Fax    
Email  gvmanoharan14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Ramkamal Balachandran 
Designation  Post graduate  
Affiliation  Sri manakula Vinayagar medical college and hospital 
Address  Department of general surgery, Sri manakula vinayagar medical college and hospital

Pondicherry
PONDICHERRY
605107
India 
Phone  7200484925  
Fax    
Email  ramkmlbala@gmail.com  
 
Source of Monetary or Material Support  
Dr.Ramkamal Balachandran Sri manakula vinayagar medical college and hospital 
 
Primary Sponsor  
Name  DrRamkamal Balachandran 
Address  57, 3rd cross, anani nagar, navarkulam, lawspet, Pondicherry India 605008 
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 
DrRamkamal Balachandran  Sri Manakula Vinayagar Medical college and hospital   Department of general surgery, SMVMCH
Pondicherry
PONDICHERRY 		 7200484925

ramkmlbala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional dressings  Conventional surgical dressing with surgical debridement with povidone iodine and normal saline, done daily for a duration of 2 weeks. 
Intervention  Nanocrystalline silver dressing   Nanocrystalline silver gel(0.02mg/g) is applied at a thickness of 2-3mm uniformly over ulcer. Frequency- Daily Duration- 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  grade 1 and 2 wagners classification
ulcer duration > 3 weeks
able to understand procedure and provide consent 
 
ExclusionCriteria 
Details  1.patients with cardiac disease, HIV, Hepatitis, critically ill patients
2.pregnancy
3.chronic venous/arterial insufficiency ulcer
4.malignant ulcer
5.Hb <7g/dl
6.Known or suspected osteomyelitis
7.ulcer <2cm size 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in wound size  Day-0, 1 week and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in granulation formation  Day-0, 1 week & 2 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/04/2024 
Date of Study Completion (India) 22/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ramkmlbala@gmail.com].

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 15-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 Diabetic foot ulcers are one of the most common complications of Diabetes mellitus with an incidence of almost 15% during the lifetime of a diabetic. Studies have shown that upto 80% of patients with diabetic foot ulcers suffer from both limb ischemia and peripheral neuropathy simultaneously. Individuals with diabetic foot ulcers are susceptible to infection and the healing process is complicated by diabetic neuropathy leading to chronic non-healing ulcers. Consequently more than 85% of lower limb amputations are preceded by foot or ankle ulcer and diabetes is one of the major causes of non-traumatic amputations across the world 
Despite high prevalence and morbidity associated with diabetic foot ulcers, current treatment options are limited. The current standard of care consists of surgical debridement followed by frequent dressing changes with strict glycemic and infection control. These ulcers not only affect the quality of life and productivity of patients but also represent a substantial financial burden for the patient and the healthcare system. 
 Antiseptic agents are used in conjugation with dressings to control bacterial load and prevent the development of infection but may also be toxic to fibroblasts and other viable cells. However, silver only has a weak toxic potential and studies have demonstrated the effectiveness of silver-based dressings against pathogenic bacteria.
The use of silver as a prophylactic and treatment for infections and other diseases dates back 1000 BC, when it was used as a disinfectant by the Greeks and Romans. Silver has antiseptic, antimicrobial, anti-inflammatory properties and is a broad spectrum antibiotic. The potency of silver as an antimicrobial was found to be related to the amount and rate of free silver released onto the wound bed. Advancements
in Nanotechnology has allowed the production of very small sized silver particles with large surface area to volume ratios which imparts greater antimicrobial efficacy and lowers toxicity to human tissue. 
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