Combination therapy for non-healing diabetic foot ulcers
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
This study is testing if a new treatment combining methylene blue and platelet-rich plasma can help heal stubborn foot ulcers in people with diabetes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Mashhad University of Medical Sciences Academic / other |
| Locations | 1 site (Mashhad, Razavi Khorasan) |
| Trial ID | NCT05850611 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining methylene blue with platelet-rich plasma-fibrin glue to enhance wound healing in patients suffering from non-healing diabetic foot ulcers. It is a randomized controlled trial involving 20 patients, where one group receives the combination treatment while the control group receives a placebo. The treatment duration is set for four weeks, focusing on improving oxygen levels in the wound area to promote healing. The study aims to provide a novel approach to a common and challenging complication of diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals with grade II to IV diabetic foot ulcers that have not improved with standard treatments for at least four weeks.
Not a fit: Patients with multiple non-healing wounds or those with significant comorbidities affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients with non-healing diabetic foot ulcers.
How similar studies have performed: While the combination of methylene blue and platelet-rich plasma-fibrin glue is a novel approach, similar studies have shown promise in enhancing wound healing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mashhad, Razavi Khorasan
- Mashhad University of Medical Sciences — Mashhad, Razavi Khorasan, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Daryoush Hamidi Alamdari, Ph.D — Mashhad University of Medical Sciences, Mashhad, Iran
- Study coordinator: Daryoush Hamidi Alamdari, Ph.D
- Email: hamidiad@mums.ac.ir
- Phone: +98 51 3882 8574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.