The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer
NCT ID: NCT05850611
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2023-04-30
2024-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Methylene Blue
The first intervention group (group A) includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention (70 mg in 200 ml of milk) for 4 weeks.
Methylene Blue
The first intervention group includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention for 4 weeks.
Milk (control)
Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks.
Milk (control)
Group B will receive 200 ml of milk for 4 weeks.
Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Patients with non-healing Diabetic Foot Ulcers will treat with PRP-Fibrin-Glue plus oral methylene blue (70 mg in 200 ml of milk) for 4 weeks.
Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.
Milk and Platelet-Rich Plasma-Fibrin Glue (control)
Patients with non-healing Diabetic Foot Ulcers will be treated with PRP-Fibrin-Glue and 200 ml of milk for 4 weeks.
Milk and Platelet-Rich Plasma-Fibrin Glue (control)
Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.
Interventions
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Methylene Blue
The first intervention group includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention for 4 weeks.
Milk (control)
Group B will receive 200 ml of milk for 4 weeks.
Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.
Milk and Platelet-Rich Plasma-Fibrin Glue (control)
Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having a single ulcer on the feet and extremities (toes, soles, heels) with no significant reduction in ulcer size (\<20%) despite the use of best treatment methods for at least four weeks
* If there is more than one non-healing wound, choose the largest wound
* The size of the wound surface (length × width) between 2 cm2 and 20 cm2
* No smoking, alcohol, and drug addiction based on the patient's self-report
* Not taking drugs that may interfere with wound healing, such as Corticosteroids, immunosuppressants, and cytotoxic agents
* Not having a concurrent chronic disease that may cause problems in wound healing, such as cancers, vasculitis, no history of known severe kidney, liver, and heart disease, such as liver cirrhosis, active hepatitis, dialysis, etc.
* Not taking antidepressants
* Insensitivity to milk lactose
* Not having Glucose 6-phosphate dehydrogenase (G6PD) deficiency
* Confirmed, informed, signed consent form
* Ankle Brachial Index (ABI) higher than or equal to 0.7
Exclusion Criteria
* The confirmed presence of osteomyelitis, or if there is suspicion of osteomyelitis
* The subject is pregnant or intends to become pregnant during the test period
* The patient is known to have mental, developmental, physical, and emotional disorders
* The occurrence of certain medical conditions
* The presence of a wound with a clear and severe infection, which is characterized by significant purulent secretions or extensive cellulitis, or gangrene requiring amputation
* Evidence of venous, ischemic, neurotrophic ulcers (numbness, tingling, lack of Achilles tendon reflex) and traumatic wounds in the patient
* Failure to refer the patient more than two times to the mentioned center for follow-up and dressing change
* Hypersensitivity reaction to methylene blue
* Platelet count less than 100,000
* The patient's lack of consent to continue cooperation
ALL
No
Sponsors
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Mashhad University of Medical Sciences
OTHER
Responsible Party
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Daryoush Hamidi Alamdari, PhD
Associate professor
Principal Investigators
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Daryoush Hamidi Alamdari, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Mashhad University of Medical Sciences, Mashhad, Iran
Locations
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Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRCT20191228045924N3
Identifier Type: -
Identifier Source: org_study_id
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