Diabetic Foot Ulcer (DFU)Phase 3C6-PDT in DFUNCT07488247
Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:
A Phase 3 study testing Chlorin E6 Gel in people with Diabetic Foot Ulcer (DFU), run by United Medical and Dental College at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Chlorin E6 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2026to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Ophthalmological disease requiring slit-lamp examination or Yag-laser within the next 30 days or anti-VEGF therapy/injection.
- Patients who do not give written informed consent
- Subjects unable or unwilling to meet protocol requirements.
- Ulcer of non-diabetic etiology, such as venous, arterial, and burn wounds
- Ulcer is less than 3 cm in distance from any other ulcer on the same extremity.
- Ulcer presents with any of the following: osteomyelitis, exposed bone or gangrene.
- Ulcer surface area has decreased > 40% between screening and at randomization (visit 1) as assessed by the imaging system
- Has medically documented history of HIV
- Has severe protein malnutrition as defined by Serum Albumin < 2.5 g/dL.
- Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal
- Has a medically documented or self-reported history, within the previous 12 months from date of screening visit, of alcohol or substance abuse.
- Has received previous treatment with the following during the 60 days prior to screening: immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the Ulcer, split- or full-thickness skin graft at the site of the Ulcer, biologically active (or engineered) cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
- Has ESR > 70 mm/h and CRP > 100 mg/L at time of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Creek General Hospital
Karachi, Sindh, 07526
Ovais M Syed, 03324622223, s.ovais@umdc.edu.pk
Huma Touheed, 0300-9890921, humatouheed@umdc.edu.pk
About this study
Official 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.
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.
Read more
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:
- 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.
Phase III:
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 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.
Secondary Objectives:
- 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. 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 screening of Phase III is started on 31-Mar-2026.
Read the detailed description
This is a single-centre, open-label, randomized Phase IIb and Phase III clinical study designed to evaluate the safety, tolerability, and efficacy of Chlorin E6 gel as a photosensitizing agent in the management of diabetic foot ulcers (DFU) using Photodynamic Therapy (PDT).
Eligible participants are adults (≥18 years) with a documented diagnosis of diabetes and chronic foot ulceration present for at least 4 weeks. In Phase IIb, 30 participants were enrolled; Phase III will include 300 participants.
The investigational product, Chlorin E6 gel (1% W/V, 1.0 mg/cm²), is applied locally to the ulcer. After 30 minutes, the ulcer is washed with saline and illuminated with red light (660-670 nm) at a dose of 100 J/cm² for 11 minutes. If required, a second illumination is performed. Standard of care (SOC) management-including wound debridement, targeted antibiotics, and optimized glycemic control-is provided to all participants.
Primary objectives are to assess safety and efficacy of Chlorin E6-mediated PDT, evaluate ulcer healing (size and depth reduction), compare healing rates with SOC alone, and determine bacterial eradication. Secondary objectives include recurrence rates and reduction in amputations within 6 months.
Endpoints include solicited local/systemic adverse events (AEs), unsolicited AEs, serious adverse events (SAEs), abnormal laboratory values, wound culture results, and healing rates (>15% at 1 week or >50% at 1 month).
The study lasted 3 months per participant in Phase IIb (completed) and 6 months per participant in Phase III, was started in March 2026.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Chlorin E6 Gel
- Keywords
- Diabetic Foot Ulcer, DFU, PDT, Photodynamic Therapy, Chlorin E6, Phase IIB of Chlorin E6, Chlorin E6 Gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorin E6 GelCombination product
The Group A participants in this study were received Chlorin E6 Gel-mediated Photodynamic Therapy for the management of Diabetic Foot Ulcers
| Study group | Role | What they receive |
|---|---|---|
| Group A (IP+PDT+SOC) | Experimental | This group will be provided with Standard of Care treatment for DFU, along with IP application and PDT Receives: Combination Product: Chlorin E6 Gel |
| Group B (SOC Only) | No intervention | This group will only receive the Standard of Care treatment for DFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse event experienced by participants
Adverse events will include those that are related to study intervention.
Measured: 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
Measured: 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
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start2 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IIB was conducted at creek general hospital and sponsored by Synverdis GmbH, Heidelberg, Germany is completed. Phase III was started on 31-Mar-2026.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Medical and Dental College
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Bioequivalence Studies and Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488247
- Sponsor's protocol ID
- CHLORIN E6-IIB-III-01
- Acronym
- C6-PDT in DFU
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schaper NC, Apelqvist J, Bakker K. The international consensus and practical guidelines on the management and prevention of the diabetic foot. Curr Diab Rep. 2003 Dec;3(6):475-9. doi: 10.1007/s11892-003-0010-4.
PubMed 14611743Oluwole DO, Coleman L, Buchanan W, Chen T, La Ragione RM, Liu LX. Antibiotics-Free Compounds for Chronic Wound Healing. Pharmaceutics. 2022 May 9;14(5):1021. doi: 10.3390/pharmaceutics14051021.
PubMed 35631606Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
PubMed 29377202Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
PubMed 28614678Borgia F, Giuffrida R, Caradonna E, Vaccaro M, Guarneri F, Cannavo SP. Early and Late Onset Side Effects of Photodynamic Therapy. Biomedicines. 2018 Jan 29;6(1):12. doi: 10.3390/biomedicines6010012.
PubMed 29382133Agostinis P, Berg K, Cengel KA, Foster TH, Girotti AW, Gollnick SO, Hahn SM, Hamblin MR, Juzeniene A, Kessel D, Korbelik M, Moan J, Mroz P, Nowis D, Piette J, Wilson BC, Golab J. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011 Jul-Aug;61(4):250-81. doi: 10.3322/caac.20114. Epub 2011 May 26.
PubMed 21617154
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07488247
- Acronym / sponsor ID
- C6-PDT in DFU / CHLORIN E6-IIB-III-01
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Diabetic Foot Ulcer, DFU, PDT, Photodynamic Therapy, Chlorin E6, Phase IIB of Chlorin E6, Chlorin E6 Gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- United Medical and Dental CollegeUniversity, hospital or other
- Collaborators
- Center for Bioequivalence Studies and Clinical Research
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Phase III:
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 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.
Secondary Objectives:
- 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. 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 screening of Phase III is started on 31-Mar-2026.
Detailed description
This is a single-centre, open-label, randomized Phase IIb and Phase III clinical study designed to evaluate the safety, tolerability, and efficacy of Chlorin E6 gel as a photosensitizing agent in the management of diabetic foot ulcers (DFU) using Photodynamic Therapy (PDT).
Eligible participants are adults (≥18 years) with a documented diagnosis of diabetes and chronic foot ulceration present for at least 4 weeks. In Phase IIb, 30 participants were enrolled; Phase III will include 300 participants.
The investigational product, Chlorin E6 gel (1% W/V, 1.0 mg/cm²), is applied locally to the ulcer. After 30 minutes, the ulcer is washed with saline and illuminated with red light (660-670 nm) at a dose of 100 J/cm² for 11 minutes. If required, a second illumination is performed. Standard of care (SOC) management-including wound debridement, targeted antibiotics, and optimized glycemic control-is provided to all participants.
Primary objectives are to assess safety and efficacy of Chlorin E6-mediated PDT, evaluate ulcer healing (size and depth reduction), compare healing rates with SOC alone, and determine bacterial eradication. Secondary objectives include recurrence rates and reduction in amputations within 6 months.
Endpoints include solicited local/systemic adverse events (AEs), unsolicited AEs, serious adverse events (SAEs), abnormal laboratory values, wound culture results, and healing rates (>15% at 1 week or >50% at 1 month).
The study lasted 3 months per participant in Phase IIb (completed) and 6 months per participant in Phase III, was started in March 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase IIB was conducted at creek general hospital and sponsored by Synverdis GmbH, Heidelberg, Germany is completed. Phase III was started on 31-Mar-2026.
| Arm | Type | Receives |
|---|---|---|
| Group A (IP+PDT+SOC) | Experimental | Combination Product: Chlorin E6 GelThis group will be provided with Standard of Care treatment for DFU, along with IP application and PDT |
| Group B (SOC Only) | No intervention | –This group will only receive the Standard of Care treatment for DFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorin E6 GelThe Group A participants in this study were received Chlorin E6 Gel-mediated Photodynamic Therapy for the management of Diabetic Foot Ulcers | Combination product | Group A (IP+PDT+SOC) |
Primary outcome
Number of adverse event experienced by participants
Time frame: 03 months
Adverse events will include those that are related to study intervention.
Efficacy of Chlorin E6-mediated PDT
Time frame: 3 months
To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers, defined by a reduction in size and depth of ulcer
Eradication Ratio of Pathogenic Bacteria
Time frame: 03 months
To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 14611743Schaper NC, Apelqvist J, Bakker K. The international consensus and practical guidelines on the management and prevention of the diabetic foot. Curr Diab Rep. 2003 Dec;3(6):475-9. doi: 10.1007/s11892-003-0010-4.
- Background: PubMed 35631606Oluwole DO, Coleman L, Buchanan W, Chen T, La Ragione RM, Liu LX. Antibiotics-Free Compounds for Chronic Wound Healing. Pharmaceutics. 2022 May 9;14(5):1021. doi: 10.3390/pharmaceutics14051021.
- Background: PubMed 29377202Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
- Background: PubMed 28614678Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
- Background: PubMed 29382133Borgia F, Giuffrida R, Caradonna E, Vaccaro M, Guarneri F, Cannavo SP. Early and Late Onset Side Effects of Photodynamic Therapy. Biomedicines. 2018 Jan 29;6(1):12. doi: 10.3390/biomedicines6010012.
- Background: PubMed 21617154Agostinis P, Berg K, Cengel KA, Foster TH, Girotti AW, Gollnick SO, Hahn SM, Hamblin MR, Juzeniene A, Kessel D, Korbelik M, Moan J, Mroz P, Nowis D, Piette J, Wilson BC, Golab J. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011 Jul-Aug;61(4):250-81. doi: 10.3322/caac.20114. Epub 2011 May 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorin E6 Gel in people with Diabetic Foot Ulcer (DFU), run by United Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse event experienced by participants (time frame: 03 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488247, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.