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. - Sofinox Gel-DWH

MS Apex Laboratories Private Limited0 个研究点目标入组 211 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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.

•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

发起方

MS Apex Laboratories Private Limited