Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:

Protocol No. CHLORIN E6-IIB/III-01/Protocol/1.1 Title:Single-Centre, open-labeled, randomized, Phase IIb and Phase III clinical studies to evaluate the safety, tolerability, and efficacy of Chlorin E6 (Gel Formation) as a photosensitizing agent for the management of Diabetic Foot Ulcers with Photodynamic Therapy. Sponsor Synverdis GmbH, Heidelberg, Germany. Study Phase: Phase IIb(Completed) \& Phase III(Ongoing) Indication : Diabetic Foot Ulcers Study Population: This study will be conducted on diabetic participants who are 18 years of age or older, with a documented diagnosis of diabetes and foot ulceration that has been present for at least 4 weeks. Sample Size of Phase IIb: 30 participants were enrolled. Phase III: 300 participants will be enrolled. Intervention Investigational Product: Chlorin E6 gel Specification: 1.0 mg/cm2 of Chlorin E6 1% W/V in gel-form Formulation: Gel Storage and Transportation: Store and ship at 2\~8°C, avoiding freezing. Standard of Care Treatment: a. Surgical Intervention: Debridement of the wound will be performed for all the participants. b. Medical Intervention: i. Antibiotics: Targeted to aerobic Gram-positive cocci in mild to moderate infections. \- Moxifloxacin * Linezolid * Co-Amoxiclav * Piperacillin + Tazobactam * Clindamycin Dosage \& Application Patients will receive 1.0 mg/cm2 of Chlorin E6 1% W/V in gel form by local application on the ulcer. Approximately 30 minutes after the study drug administration, the ulcer will be washed thoroughly with normal saline. Then it will be illuminated with light at 660 to 670 nm from an approved laser source with a calculated light dose of 100 J/cm2. Light will be applied to the entire surface of the ulcer for 11 minutes. The wound will then be illuminated with UV light to assess the effectiveness of Photodynamic Therapy (PDT) and a further 11 minutes of therapy will be carried out if required. Study Objectives Phase IIb: Primary Objectives: 1. To determine the safety and effica