The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

Launched by MASHHAD UNIVERSITY OF MEDICAL SCIENCES · Apr 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with diabetic foot ulcers that are not healing properly. The researchers want to see if combining two treatments, methylene blue (which helps improve oxygen in the wound area) and platelet-rich plasma-fibrin glue (which promotes healing), can help these stubborn wounds heal better. The goal is to find a more effective way to support healing in patients who have had little success with standard treatments.

To be part of this study, participants must have a single diabetic foot ulcer that has not significantly improved despite receiving the best available care for at least four weeks. They should not smoke, have specific chronic diseases, or take certain medications that could interfere with healing. If eligible, participants can expect to receive the new treatment and be closely monitored throughout the trial. It's important to know that the trial is currently recruiting and aims to help improve healing for those struggling with diabetic foot ulcers.

Gender

ALL

Eligibility 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:
• • Do not be treated with methylene blue
• • 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