An Early Phase 1 interventional study of Methylene Blue and Milk (control) in Diabetic Foot Ulcers and Diabetic Wound, sponsored by Mashhad University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Mashhad University of Medical Sciences · Early Phase 1, Interventional, and Treatment
The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.
The current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing DFU). This randomized controlled trial is performed on 20 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus 200 ml of oral methylene blue dissolved in milk(intervention group) or PRP-FG dressing plus placebo (200 ml of milk) (control group) for 4 weeks.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Mashhad University of Medical Sciences is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first intervention group (group A) includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention (70 mg in 200 ml of milk) for 4 weeks.
Drug: Methylene Blue
Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks.
Other: Milk (control)
Patients with non-healing Diabetic Foot Ulcers will treat with PRP-Fibrin-Glue plus oral methylene blue (70 mg in 200 ml of milk) for 4 weeks.
Drug: Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Patients with non-healing Diabetic Foot Ulcers will be treated with PRP-Fibrin-Glue and 200 ml of milk for 4 weeks.
Other: Milk and Platelet-Rich Plasma-Fibrin Glue (control)
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.
Also known as: Methylthioninium chloride
Group B will receive 200 ml of milk for 4 weeks.
Also known as: Placebo
Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.
Also known as: Methylthioninium chloride and PRP-Fibrin Glue
Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.
Also known as: Placebo
The healing rate of the ulcer
Measurement of wound area with a ruler
Time frame: 4 weeks
Wound Size
Wound size will be measured with a ruler for length, and width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound.
Time frame: 4 weeks
TcPO2 at baseline and after the intervention
Transcutaneous oxygen tension (TcpO2) provides information about blood perfusion in the tissue immediately below the skin. (blood pressure, measured in millimeters of mercury (mmHg))
Time frame: 4 weeks
Oxygen saturation at baseline and after the intervention
Blood must contain a normal concentration of hemoglobin. that hemoglobin must be \>95 % saturated with oxygen in arterial blood (sO2(a) \>95 %)
Time frame: 4 weeks
Blood pressure (systolic and diastolic)
The pressure of the blood in the circulatory system
Time frame: 4 weeks
The resting systolic toe pressure (TP) at baseline and after the intervention
The toe cuff with the sphygmomanometer is slowly inflated until the waveform flattens (generally between 150-200 mmHg), then is inflated a further 20 mmHg. The cuff is slowly released at a rate of 2-5mmHg per second. The first regular cyclical waveform is considered the toe systolic pressure.
Time frame: 4 weeks
Serum IL-1β levels at baseline and after the intervention
Analysis of serum interleukin-1β levels
Time frame: 4 weeks
Serum MCP-1 levels at baseline and after the intervention
Analysis of serum monocyte chemoattractant protein-1 (MCP-1) levels
Time frame: 4 weeks
Serum TNF-α levels at baseline and after the intervention
Analysis of serum tumor necrosis factor α (TNFα) levels
Time frame: 4 weeks
Serum IL-6 levels at baseline and after the intervention
Analysis of serum interleukin-6 (IL-6) levels
Time frame: 4 weeks
Serum HIF-1α levels at baseline and after the intervention
Analysis of serum hypoxia-inducible factor 1-alpha (HIF-1α) levels
Time frame: 4 weeks
Serum FBS levels at baseline and after the intervention
Analysis of serum fasting blood sugar (FBS ) levels
Time frame: 4 weeks
Serum Insulin levels at baseline and after the intervention
Analysis of Insulin levels
Time frame: 4 weeks
Lipid Profile at baseline and after the intervention
Serum Triglyceride, Cholesterol, HDL, LDL, VLDL
Time frame: 4 weeks
Serum Urea at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Creatinine at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum total bilirubin at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Vitamin D levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
HbA1c at baseline and after the intervention
Glycated hemoglobin
Time frame: 4 weeks
Serum Albumin (Alb) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Uric Acid levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Homocysteine levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum ALT (alanine transaminase) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum AST (Aspartate Transferase) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum ALP (alkaline phosphatase) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Met Hemoglobin levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Hemoglobin (Hgb, Hb) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum white blood cells (WBCs) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum total Lymphocyte levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Platelet count at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Nitric oxide blood at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum lactate dehydrogenase (LDH) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum Erythrocyte Sedimentation Rate (ESR) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Serum C-Reactive Protein (CRP) levels at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Neutrophils count at baseline and after the intervention
In a quantitative laboratory method
Time frame: 4 weeks
Plan to share: Yes — All data related to the project after the unidentifiable people will be shared.
Supporting information: Study protocol, Informed consent form
Time frame: Access to data is allowed 6 months after the publication of results.
Access criteria: The investigator's data will be available to university staff and academic institutions.
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Aug 2023, 3 months.
Of 26 phase 1 interventional studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's 3 months is below that.
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Studies of the drug tested here: Methylene Blue
Mashhad University of Medical Sciences