Non-healing diabetic foot ulcer. Diabetes mellitus with peripheral circulatory complications. Diabetic ulcer
Conditions
Interventions
Intervention group: 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, and
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area. Timepoint: Every week for a month after dressing. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Need to amputation. Timepoint: Every week for a month after dressing. Method of measurement: Clinical observation, lab data. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDaryoush Hamidi Alamdari
Mashhad University of Medical Sciences
Outcome results
None listed