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IRCT20191228045924N3 IRCT 2023-02-09 Mashhad University of Medical Sciences The effect of combination therapy of oral methylene blue and fibrin glue in the treatment of non-healing diabetic foot ulcer The effect of combination therapy of oral methylene blue and platelet-rich plasma-fibrin glue in patients with non-healing diabetic foot ulcer: a pilot study 2023-04-04 anticipated 20 Complete https://irct.ir/trial/68321 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, permuted block randomization will be used to randomly allocate a participant to a treatment group while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignments. The sealed envelope is used as a means of randomization and allocation concealment, Blinding description: First, the study will be explained to the participants that it is a double-blind study and includes two intervention groups and two control groups. One group will be given methylene blue along with milk for 4 weeks and one group will be received only milk for 4 weeks. The other group will be treated with a 4-week synergistic treatment of oral methylene blue with fibrin glue, and its control group will be treated with fibrin glue and milk for 4 weeks. Methylene blue is reduced when it dissolves in milk and the color of the milk does not change. The participants will not know about the content of the milk and which group they belong to. The statistical analyzer is not also informed about the groups. 2 Non-healing diabetic foot ulcer. 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 the second intervention group consists of diabetic patients with chronic foot ulcers will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3841 2081 hamidiad@mums.ac.ir Mashhad University of Medical Sciences scientific Daryoush Hamidi Alamdari
Daneshgah Street, Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
Mashhad Iran (Islamic Republic of) 9133913716 +98 915 101 7650 hamidiad@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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 E10-E14 Diabetes mellitus with peripheral circulatory complications. Diabetic ulcer Treatment - Drugs 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 the second intervention group consists of diabetic patients with chronic foot ulcers will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue. Wound area. Timepoint: Every week for a month after dressing. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. Need to amputation. Timepoint: Every week for a month after dressing. Method of measurement: Clinical observation, lab data. Mashhad University of Medical Sciences Approved 2023-01-28 Research Ethics committees of Mashhad University of Medical Sciences Daneshgah street, the central organization of University, Quraishi construction Mashhad Razavi Khorasan Iran (Islamic Republic of)