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CTRI Number  CTRI/2019/07/020319 [Registered on: 22/07/2019] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Testing of Sofinox Gel on Diabetic Wound ulcer patients 
Scientific Title of Study   A Multicentric, Open label, Randomized, Phase III, Study on the Safety and Efficacy of Sofinox Gel (SODIUM FUSIDATE equivalent to FUSIDIC ACID 2%w/w) in Diabetic Wound Healing.  
Trial Acronym  Sofinox Gel-DWH 
Secondary IDs if Any  
Secondary ID  Identifier 
DUW–SHG/ IN-01 version 001 Dated on 24/04/2018  Protocol Number 
DUW–SHG/ IN-01 version 002 Dated on 04/08/2018  Protocol Number 
DUW–SHG/ IN-01 version 003 Dated 10/04/2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RB Sudagar singh  
Designation  Medical affairs, Professor of Medicine 
Affiliation  Apex Laboratories Private Limited/ Sri Ramachandra University 
Address  Room no 7, M/S Apex Laboratories Private limited SIDCO garment complex III floor, Guindy Chennai-600032. Tamil Nadu, India.

Chennai
TAMIL NADU
600032
India 
Phone    
Fax    
Email  drsingh7071@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RB Sudagar singh  
Designation  Professor, Department of General Medicine 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Room no 7, Department of General Medicine,Udayar block, No 1, Ramachandra Nagar, Sri Ramachandra Medical Centre,Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  drsingh7071@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrLRamanathan 
Designation  Senior Manager, Regulatory affairs 
Affiliation  Apex Laboratories Private Limited 
Address  Room no 21, M/S Apex Laboratories Private limited SIDCO garment complex III floor, Guindy Chennai-600032. Tamil Nadu, India.Chennai
ramanathan@apexlab.com
Chennai
TAMIL NADU
600032
India 
Phone    
Fax    
Email  apexsrmc@gmail.com  
 
Source of Monetary or Material Support  
MS Apex Laboratories Private Limited, SIDCO farment complex III floor, Guindy chennai 600032. Tamil Nadu, India 
 
Primary Sponsor  
Name  MS Apex Laboratories Private Limited 
Address  M/S Apex Laboratories Private limited SIDCO garment complex III floor, Guindy Chennai-600032. Tamilnadu, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi BN  Adichunchungiri Hospital & Research Centre  Adichunchungiri Unviversity, B.G.Nagara, Nagamangal Mandya, Karnataka
Mandya
KARNATAKA 		 9448323893

ravibn972@yahoo.com 
DrMD Thenmozhi Plastic surgeon  Priyam Speciality Hospital  Bangalore Bypass Road, AH43, Kondalampatti, Salem, Tamil Nadu -63601
Salem
TAMIL NADU 		 9894417565

drnirmalson@gmail.com 
Dr P Surendran  Sri Ramachandra Hospital   Department of Surgery, G-Block, Room no 9, Sri Ramachandra Hospital, No 1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU 		 9840230306

drsuru@yahoo.com 
Dr R Radhakrishnan  Sri Ramachandra Medical Centre  Department of Vascular Surgery,Udayar block,Room no 14 Sri Ramachandra Medical Centre, No 1 Ramachandra Nagar, porur, Chennai
Chennai
TAMIL NADU 		 9840073083

rrkrishnan@hotmail.com 
Dr TV Raja  Visa Hospital  Visa Hospital, No 27, South West Boag Road, T Nagar.
Chennai
TAMIL NADU 		 9841038388

visahospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC DHARAN HOSPITALRESERACH CENTRE  Approved 
IEC-Adichunchangiri Institute of Medical Sciences  Approved 
IECUNIVERSALETHICS COMMITTEE  Approved 
Sri Ramachandra insitutional Ethics Committee  Approved 
Sri Ramachandra Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L978||Non-pressure chronic ulcer of other part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not applicable 
Intervention  Sofinox Gel  EVEN THOUGH FUSIDIC ACID AS A MOLECULE POSSESSES A STEROIDAL CORE STRUCTURE IT DOES NOT EXPRESS ITSELF FOR ANTI-INFLAMMATORY & IMMUNOSUPPRESSIVE EFFECTS IN MEDICAL TREATMENT. BUT FUSIDIC ACID IN SOFINOX GEL IS ACHIEVED WITH A SUB-MICRON PARTICLE SIZE WHERE THE CORE STEROIDAL EFFECT GETS EXPRESSED BY THE PENETRATION ACHIEVED DUE TO ITS LOW PARTICLE SIZE”. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Men or women aged between 18 and 65 years, with diabetic ulcers.
2. Diabetic ulcer
a. Single full-thickness ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles. Chronic ulcer of at least four weeks despite appropriate wound care. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
b. Well controlled infection or cellulitis (systemic antibiotherapy).
c. Adequate arterial blood supply to be measured, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification).
3. Signed informed consent before any study procedure is initiated.
 
 
ExclusionCriteria 
Details  1. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
2. Any evidence of Osteomyelitis assessed by the clinician radiographically.
3. HbA1c (≥9.0), Renal failure (serum creatinine >3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
4. Known connective tissue or malignant disease.
5. Concomitant treatment with corticosteroids,
6. Immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
7. Use of investigational drug/device within 30 days.
8. Topical application of any advanced wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 30 days.
9. Surgical procedure to treat venous or arterial disease within the last 4 weeks.
10. Patients with hypersensitivity to fusidic acid.
11. Patients with hypersensitivity to gel and collagen.
12. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
13. Patient with cardiovascular disease or intermittent claudication or stroke.
14. Pregnant women will be excluded from the study.
15. Ankle brachial pressure index should not be greater than 1.3
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Complete healing is defined as full 100% epithelialisation or skin closure without drainage  24 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of reduction in ulcer size from baseline to 24 weeks.

 		 24 Weeks 
 
Target Sample Size   Total Sample Size="312"
Sample Size from India="312" 
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 3 
Date of First Enrollment (India)   22/07/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

We conducted phase III clinical study titled “A Multicentric, Open label, Randomized, Phase III Study on the Safety and Efficacy of Sofinox Gel (SODIUM FUSIDATE equivalent to FUSIDIC acid 2%w/w) in Diabetic Wound Healing” with protocol no: DUW-SHG IN-01, Version 03 dated 10/04/2019.

Study Summary as follows:

Study Type

Phase III Clinical study

Study Design

Multicentric, Open label, Randomized

No. of. Arms

02

Type of arms

Arm 1 : Sofinox Gel + Standard of Care (SOC)

Arm 2 : Standard of Care + Normal Saline Wash

Study Duration

14 weeks

Study Start Date

24 Jul 19 (First patient screened)

Study End Date

09 Feb 22 (Last subject last visit)

Total no. of. Study sites

12

Total no. of. Subjects planned initially

312

Actual no. of. Subjects recruited in the study

211

Due to COVID -19 pandemic and mass quarantine across the country, patient recruitment was highly challenged. In spite of very toughest and hard core pandemic period Apex laboratories have given its sincere efforts for recruiting diabetic wound ulcer patients for the Phase III clinical study.  

Regulatory query and its response

After submission of the clinical study report (DUW-SHG IN-01, version 01 dated 20 Dec 2023) on 24 Dec 2023. A query has been received on 07 Mar 24 from SEC stating “After detailed deliberation, the committee opined that the firm should complete clinical trial as per the approved protocol and submit the clinical trial report to the CDSCO for further review by the committee” Response from the firm regarding the waiver of clinical trial has been submitted to the SEC and CDSCO authority on 18 Mar 24 with the sample size justification utilized in the Sofinox Gel phase III study. With respect to the waiver of clinical trial submitted by Apex, the CDSCO and SEC responded stating that “The Justification submitted was examined by this office and it is concluded that justification submitted by you is not considerable and you are required to complete the clinical trial by recruiting 312 participants as per original sample size calculation and submit the complete clinical trial report to this office for taking further necessary action in the matter” Apex laboratory responded to the SEC and CDSCO authority on 18 Jun 2024, with global diabetic foot ulcer clinical research study literature data along with average dropout subject and % of wound healing rates for various test products.

Submitted literature evidence and provided sample size justification were not considered by the CDSCO authority and 10 Jan 2025, they recommended to complete clinical trial study by recruiting 312 patients, as per original sample size calculation of the protocol.

Based on continuous recommendation, by CDSCO and SEC experts, it was planned to conduct an extended Phase III to fulfill the withheld sample size from Phase III study of the same product to generate the additional evidence for its approval to manufacture and market the same. Sponsor has requested us to extend the recruitment and to support for the completing the study


 
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