Chlorin-e6

Protocol No. CHLORIN E6-IIB/III-01/Protocol/1.1 Study 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.
Version No. 1.1 Version Date 01-Aug-2024 Sponsor Synverdis GmbH, Heidelberg, Germany. Study Phase Phase IIb & Phase III Indication : Diabetic Foot Ulcers Study Population This study will be conducted on diabetic subjects 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 Phase IIb: 30 subjects was enrolled. Phase III: 300 subjects 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 efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.
2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by a reduction in size and depth of the ulcer.
3. To compare the efficacy and healing rates of Diabetic foot ulcers with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care (SOC) management.
4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.
Phase III:
Primary Objectives:
1. To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.
2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by reduction in size and depth of ulcer.
3. To compare the efficacy and rates of healing of Diabetic Foot Ulcer (DFU) with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care management.
4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.
Secondary Objectives:
1. To determine the rates of recurrence of diabetic foot ulcers during 6 months after local Chlorin E6-mediated Photodynamic Therapy.
2. To determine the reduction in rates of amputation during 6 months after local Chlorin E6-mediated Photodynamic Therapy.
Study Endpoints Phase IIb:
Primary endpoints:
Safety:
• Solicited local and systemic AEs within 30 minutes and 7 days after product administration/application;
Secondary endpoints:
Safety:
• Unsolicited AEs within 28 days after product administration/application;
• SAEs throughout 3 months after product administration/application;
• Abnormal laboratory value analysis on Day 14 after product administration/application;
Efficacy:
• No growth on culture of wound base swab at 1 week after product administration/ application.
* Rate of healing > 15 % in 1 week or >50% in 1 month
Phase III:
Primary endpoints:
Safety:
* Solicited local and systemic AEs within 30 minutes and 7 days after product administration/application;
Secondary endpoints:
Safety:
* Unsolicited AEs within 28 days after product administration/application;
* SAEs throughout 6 months after product administration/application;
* Abnormal laboratory value analysis on Day 14 after product administration/application;
Efficacy:
* No growth on culture of wound base swab at 1 week after product administration/ application.
* Rate of healing > 15 % in 1 week or >50% in 1 month.
Phase IIB of this trial is completed and Phase III will be initiated in the last week of March 2026.