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

NCT07488247 | Completed Phase 2 DMC

• 1 other identifier: CHLORIN E6-IIB-III-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.
• 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.
• 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.
• To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.
• To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.
• To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by reduction in size and depth of ulcer.
• 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.
• To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.
• To determine the rates of recurrence of diabetic foot ulcers during 6 months after local Chlorin E6-mediated Photodynamic Therapy.
• To determine the reduction in rates of amputation during 6 months after local Chlorin E6-mediated Photodynamic Therapy.
• 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.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

Diabetic Foot Ulcer; DFU; PDT; Photodynamic Therapy; Chlorin E6; Phase IIB of Chlorin E6; Chlorin E6 Gel

Outcome Measures

Primary Outcomes (3)

• Number of adverse event experienced by participants

  Adverse events will include those that are related to study intervention.

  03 months

• Efficacy of Chlorin E6-mediated PDT

  To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers, defined by a reduction in size and depth of ulcer

  3 months

• Eradication Ratio of Pathogenic Bacteria

  To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy

  03 months

Study Arms (2)

Group A (IP+PDT+SOC)

EXPERIMENTAL

This group was provided with Standard of Care treatment for DFU, along with IP application and PDT

Combination Product: Chlorin E6 Gel

Group B (SOC Only)

NO INTERVENTION

This group was only receive the Standard of Care treatment for DFU

Interventions

Chlorin E6 Gel COMBINATION_PRODUCT

The Group A participants in this study were received Chlorin E6 Gel-mediated Photodynamic Therapy for the management of Diabetic Foot Ulcers

Group A (IP+PDT+SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of Diabetes mellitus, with diabetic foot ulcer.
• Males and females subject of age 18 years and above.
• HbA1c of less than 12% and random blood sugars of less than 350 mg/dl.
• Vitally stable patient with no clinical signs of sepsis, a qSOFA (quick Sepsis-Related Organ Failure Assessment) score of \<2.
• ABI (Ankle Brachial Index) 0.7 to 1.2.
• Lower extremity ulcer of more than 30 days duration and less than 2 years duration.
• Total wound surface area between 0.5 to 20 cm.
• Deep wounds extending up to muscles (University of Texas Grade \& Stage 1A, 1B, 2A \& 2B) will be included.
• Patients giving written informed consent to participate in the study after a full understanding of the implications and constraints of the study protocol.
• Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed).
• The subject can understand the research process and is willing and able to comply with all research proposals and other requirements of the study.
• Able to cooperate to complete the scheduled follow-ups till the end of the study

You may not qualify if:

• The vital signs or physical examination are clinically significantly abnormal as determined by the investigators in screening.
• A history of severe allergy (including drugs, vaccines, and foods) or allergy to any component of the experimental product.
• Subjects diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to serious: respiratory disease, cardiovascular disease, serious cerebrovascular disease, kidney disease, serious or uncontrollable diabetes, autoimmune disease, thrombocytopenic purpura, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study;
• Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study;
• Other circumstances considered by the investigator as inappropriate to participate in the study.
• Vitally unstable patients with clinical signs and symptoms of sepsis, qSOFA score ≥2.
• More than 2 ulcers in the foot and leg.
• Deep wounds extending into bone (UoT Criteria any Grade stage C \& D, Grade 3).
• Subjects with moderate to severe obstruction on ABI (\<0.7 or \>1.3).
• Patients with HbA1c more than 12% and random blood sugar of more than 350 mg /dl.
• Subjects with evidence of cardiac disease or heart failure on ECG or echocardiography
• Patients with eGFR (Estimated Glomerular Filtration Rate) of less than 60 ml/min/1.73 m2.
• Pregnant or breast-feeding females or women of childbearing potential not using contraception.
• Hypersensitivity to investigational product/Chlorophyll-driven compounds.
• Diagnosed case of porphyria.

Sponsors & Collaborators

• United Medical and Dental College: lead
• Center for Bioequivalence Studies and Clinical Research: collaborator

Study Sites (1)

Creek General Hospital

Karachi, Sindh, 07526, Pakistan

Location

Related Publications (6)

• Schaper, N. C., Apelqvist, J., & Bakker, K. (2000). The International Consensus and practical guidelines on the management and prevention of the diabetic foot. Current Diabetes Reports, 3(6), 475-479. https://doi.org/10.1007/s11892-003-0010-4

  BACKGROUND

• Oluwole, D. O., Chen, T., & Liu, L. X. (2022). Antibiotics-Free compounds for chronic wound healing. Pharmaceutics, 14(5), 1021. https://doi.org/10.3390/pharmaceutics14051021

  BACKGROUND

• Everett, E., & Mathioudakis, N. (2018). Update on management of diabetic foot ulcers. Annals of the New York Academy of Sciences, 1411(1), 153-165. https://doi.org/10.1111/nyas.13569

  BACKGROUND

• Armstrong, D. G., Boulton, A. J., & Bus, S. A. (2017). Diabetic foot ulcers and their recurrence. The New England Journal of Medicine, 376(24), 2367-2375. https://doi.org/10.1056/nejmra1615439

  BACKGROUND

• Borgia, F., Giuffrida, R., Caradonna, E., Vaccaro, M., Guarneri, F., & Cannavò, S. P. (2018). Early and late onset side effects of photodynamic therapy. Biomedicines, 6(1), 12. https://doi.org/10.3390/biomedicines6010012

  BACKGROUND

• Agostinis, P., Berg, K., Cengel, K. A., Foster, T. H., Girotti, A. W., Gollnick, S. O., Hahn, S. M., Hamblin, M. R., Juzeniene, A., Kessel, D., Korbelik, M., Moan, J. E., Mróz, P., Nowis, D., Piette, J., Wilson, B. C., & Gołąb, J. (2011). Photodynamic therapy of cancer: An update. CA: A Cancer Journal for Clinicians, 61(4), 250-281. https://doi.org/10.3322/caac.20114

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a Phase IIB clinical trial of Chlorin E6 Gel which was conducted at creek general hospital and sponsored by Synverdis GmbH, Heidelberg, Germany. Phase III of this clincial trail will be conducted very soon.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 23, 2026
• Study Start: June 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: February 20, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

PA (1)