The effect of combination therapy of oral methylene blue and fibrin glue in the treatment of non-healing diabetic foot ulcer

Phase 2

Conditions: on-healing diabetic foot ulcer.
Diabetes mellitus with peripheral circulatory complications. Diabetic ulcer
E10-E14

Registration Number: IRCT20191228045924N3

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 20

Inclusion Criteria

Having a Diabetic ulcer grade II and IV based on Wagner's classification on the sole, medial, or lateral part of the foot (including all surfaces of the toes)
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

Do not be treated with methylene blue
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