Testing of Sofinox Gel on Diabetic Wound ulcer patients

Phase 3

Recruiting

Conditions: Non-pressure chronic ulcer of other part of lower leg,

Registration Number: CTRI/2019/07/020319

Lead Sponsor: MS Apex Laboratories Private Limited

Brief Summary: 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:**

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| --- | --- |

|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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 312

Inclusion Criteria

Men or women aged between 18 and 65 years, with diabetic ulcers.
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 cmÂ², both inclusive.
Well controlled infection or cellulitis (systemic antibiotherapy).
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).

Exclusion Criteria

Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
Any evidence of Osteomyelitis assessed by the clinician radiographically.
HbA1c (â‰¥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).
Known connective tissue or malignant disease.
Immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
Use of investigational drug/device within 30 days.
Topical application of any advanced wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 30 days.
Surgical procedure to treat venous or arterial disease within the last 4 weeks.
Patients with hypersensitivity to fusidic acid.
Patients with hypersensitivity to gel and collagen.
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.
Patient with cardiovascular disease or intermittent claudication or stroke.
Ankle brachial pressure index should not be greater than 1.3.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Complete healing is defined as full 100% epithelialisation or skin closure without drainage	24 Weeks

Secondary Outcome Measures

Name	Time	Method
1. Percentage of reduction in ulcer size from baseline to 24 weeks.

Trial Locations

Locations (15): Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Medical Sciences,
🇮🇳
Wardha, MAHARASHTRA, India
Adichunchungiri Hospital & Research Centre
🇮🇳
Mandya, KARNATAKA, India
AIIMS RAIPUR
🇮🇳
Raipur, CHHATTISGARH, India
Alpha Hospital & Research Centre
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Madurai, TAMIL NADU, India
Hycare for Wounds,
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Chennai, TAMIL NADU, India
Institute of Medical Sciences and Sum Hospital
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Khordha, ORISSA, India
KLES, Dr. Prabhakar Kore Hospital and Medical research centre,
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Belgaum, KARNATAKA, India
Monika Diabetes centre
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Erode, TAMIL NADU, India
Priyam Speciality Hospital
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Salem, TAMIL NADU, India
SARAVANA MULTISPECIALITY HOSPITAL PVT LTD
🇮🇳
Madurai, TAMIL NADU, India
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Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Medical Sciences,
🇮🇳Wardha, MAHARASHTRA, India
Dr Chandrashekhar C Mahakalkar Prof of Surgery
Principal investigator
9822369277
cmahakalkar@rediffmail.com