The international consensus and practical guidelines on the management and prevention of the diabetic foot.
Nicolaas C Schaper, Jan Apelqvist, Karel Bakker
https://pubmed.ncbi.nlm.nih.gov/14611743Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07488247
Phase IIb and Phase III Studies to Evaluate Safety and Efficacy of Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers
Led by United Medical and Dental College · Updated on 2026-04-07
300
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
United Medical and Dental College
Lead Sponsor
C
Center for Bioequivalence Studies and Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of Chlorin E6 gel as a photosensitizing agent in treating diabetic foot ulcers using Photodynamic Therapy (PDT). This study includes adults aged 18 years or older with diabetes and foot ulcers lasting at least 4 weeks. The trial has completed Phase IIb with 30 participants and is currently conducting Phase III with 300 participants to compare healing rates and bacterial eradication between treatment with Chlorin E6 plus standard care versus standard care alone. Participants receive Chlorin E6 gel (1% concentration, 1.0 mg/cm2) applied locally to the ulcer. After 30 minutes, the wound is cleaned and exposed to red light (660-670 nm) for 11 minutes to activate the therapy. If needed, a second 11-minute light treatment is given. All participants also receive standard care including wound debridement and targeted antibiotics. The study has two groups: one receiving Chlorin E6 with PDT plus standard care, the other receiving standard care only. During the study, participants are monitored for safety and healing progress over 3 months in Phase IIb and 6 months in Phase III. Assessments include checking for local and systemic adverse events shortly after treatment and over several weeks, lab tests, wound cultures, and measuring ulcer size and depth. The study also tracks ulcer recurrence and amputation rates for 6 months following therapy. Participants complete scheduled follow-ups to support thorough evaluation of the treatment effects and safety.
CONDITIONS
Brief Title
Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with diabetes mellitus and diabetic foot ulcer
- Male and female participants aged 18 years and older
- HbA1c less than 12% and random blood sugar below 350 mg/dl
- Stable vital signs with no clinical signs of sepsis and qSOFA score less than 2
- Ankle Brachial Index (ABI) between 0.7 and 1.2
- Foot ulcer lasting more than 30 days and less than 2 years
- Wound surface area between 0.5 and 20 cm²
- Deep wounds extending to muscles (University of Texas Grade & Stage 1A, 1B, 2A & 2B)
- Willing and able to provide written informed consent
- Able to understand and comply with study procedures
- Able to complete scheduled follow-up visits
You will not qualify if you...
- Clinically significant abnormal vital signs or physical exam
- History of severe allergy or allergy to study product components
- Serious chronic diseases affecting study completion (e.g., severe respiratory, cardiovascular, cerebrovascular, kidney disease, autoimmune disease, cancer)
- Participation in other clinical trials within 3 months
- Vital instability with signs of sepsis and qSOFA score 2 or higher
- More than 2 ulcers on foot or leg
- Deep wounds extending into bone (University of Texas Grade & Stage C & D, Grade 3)
- ABI less than 0.7 or greater than 1.3
- HbA1c above 12% or random blood sugar above 350 mg/dl
- Cardiac disease or heart failure detected by ECG or echocardiography
- Estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73 m²
- Pregnant or breastfeeding women or women of childbearing potential not using contraception
- Hypersensitivity to investigational product or chlorophyll compounds
- Diagnosed porphyria
- Eye diseases requiring certain eye exams or treatments within 30 days
- Unable or unwilling to give informed consent
- Ulcers from non-diabetic causes
- Ulcer less than 3 cm from another ulcer on same limb
- Presence of osteomyelitis, exposed bone, or gangrene in ulcer
- Ulcer surface area decreased more than 40% between screening and randomization
- History of HIV infection
- Severe protein malnutrition (Serum Albumin less than 2.5 g/dL)
- Elevated liver enzymes more than twice upper normal limit
- History of alcohol or substance abuse in past 12 months
- Recent treatment with immunosuppressants, chemotherapy, skin grafts, or investigational drugs/devices
- Elevated ESR above 70 mm/h or CRP above 100 mg/L at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive Chlorin E6 Gel Photodynamic Therapy applied locally to the ulcer, followed by red light illumination. Standard of Care including wound care and glycemic control is provided to all participants.
Regular visits for treatment and monitoring throughout the study period
Follow-up
Duration - Up to 6 months
Participants are monitored for safety, ulcer healing, bacterial eradication, and recurrence rates after treatment.
Scheduled follow-up visits throughout the study duration
Trial Site Locations
Total: 1 location
1
Creek General Hospital
Karachi, Sindh, Pakistan, 07526
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Antibiotics-Free Compounds for Chronic Wound Healing.
David O Oluwole, Lucy Coleman, William Buchanan...
https://pubmed.ncbi.nlm.nih.gov/35631606Update on management of diabetic foot ulcers.
Estelle Everett, Nestoras Mathioudakis
https://pubmed.ncbi.nlm.nih.gov/29377202Diabetic Foot Ulcers and Their Recurrence.
David G Armstrong, Andrew J M Boulton, Sicco A Bus
https://pubmed.ncbi.nlm.nih.gov/28614678Early and Late Onset Side Effects of Photodynamic Therapy.
Francesco Borgia, Roberta Giuffrida, Emanuela Caradonna...
https://pubmed.ncbi.nlm.nih.gov/29382133Photodynamic therapy of cancer: an update.
Patrizia Agostinis, Kristian Berg, Keith A Cengel...
https://pubmed.ncbi.nlm.nih.gov/21617154