Diabetic Foot UlcersEarly Phase 1NCT05850611
The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer
A Early Phase 1 study testing Methylene Blue and Methylene Blue and Platelet-Rich Plasma-Fibrin Glue in people with Diabetic Foot Ulcers and Diabetic Wound, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetic Wound
- What is being tested?
- Methylene Blue and Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 30 Apr 2023to 21 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 99191-91778
Daryoush Hamidi Alamdari, Ph.D, 98 51 3882 8574, hamidiad@mums.ac.ir
Elaheh Emadi, Ph.D, 98 9355850931, EmadiE4001@mums.ac.ir
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcers, Diabetic Wound
- Being tested
- Methylene Blue, Milk (control), Methylene Blue and Platelet-Rich Plasma-Fibrin Glue, Milk and Platelet-Rich Plasma-Fibrin Glue (control)
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, DFU, Methylene blue, Non-healing Diabetic Foot Ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called Methylthioninium chloride
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.
Milk (control)Other
Also called Placebo
Group B will receive 200 ml of milk for 4 weeks.
Methylene Blue and Platelet-Rich Plasma-Fibrin GlueDrug
Also called Methylthioninium chloride and PRP-Fibrin Glue
Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.
Milk and Platelet-Rich Plasma-Fibrin Glue (control)Other
Also called Placebo
Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | 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. Receives: Drug: Methylene Blue |
| Milk (control) | Experimental | Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks. Receives: Other: Milk (control) |
| Methylene Blue and Platelet-Rich Plasma-Fibrin Glue | Experimental | 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. Receives: Drug: Methylene Blue and Platelet-Rich Plasma-Fibrin Glue |
| Milk and Platelet-Rich Plasma-Fibrin Glue (control) | Experimental | Patients with non-healing Diabetic Foot Ulcers will be treated with PRP-Fibrin-Glue and 200 ml of milk for 4 weeks. Receives: Other: Milk and Platelet-Rich Plasma-Fibrin Glue (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The healing rate of the ulcer
Measurement of wound area with a ruler
Measured: 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.
Measured: 4 weeks
Secondary outcomes (33)
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))
Measured: 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 %)
Measured: 4 weeks
Blood pressure (systolic and diastolic)
The pressure of the blood in the circulatory system
Measured: 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.
Measured: 4 weeks
Serum IL-1β levels at baseline and after the intervention
Analysis of serum interleukin-1β levels
Measured: 4 weeks
Serum MCP-1 levels at baseline and after the intervention
Analysis of serum monocyte chemoattractant protein-1 (MCP-1) levels
Measured: 4 weeks
Serum TNF-α levels at baseline and after the intervention
Analysis of serum tumor necrosis factor α (TNFα) levels
Measured: 4 weeks
Serum IL-6 levels at baseline and after the intervention
Analysis of serum interleukin-6 (IL-6) levels
Measured: 4 weeks
Serum HIF-1α levels at baseline and after the intervention
Analysis of serum hypoxia-inducible factor 1-alpha (HIF-1α) levels
Measured: 4 weeks
Serum FBS levels at baseline and after the intervention
Analysis of serum fasting blood sugar (FBS ) levels
Measured: 4 weeks
Serum Insulin levels at baseline and after the intervention
Analysis of Insulin levels
Measured: 4 weeks
Lipid Profile at baseline and after the intervention
Serum Triglyceride, Cholesterol, HDL, LDL, VLDL
Measured: 4 weeks
Serum Urea at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Creatinine at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum total bilirubin at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Vitamin D levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
HbA1c at baseline and after the intervention
Glycated hemoglobin
Measured: 4 weeks
Serum Albumin (Alb) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Uric Acid levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Homocysteine levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum ALT (alanine transaminase) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum AST (Aspartate Transferase) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum ALP (alkaline phosphatase) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Met Hemoglobin levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Hemoglobin (Hgb, Hb) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum white blood cells (WBCs) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum total Lymphocyte levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Platelet count at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Nitric oxide blood at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum lactate dehydrogenase (LDH) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum Erythrocyte Sedimentation Rate (ESR) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Serum C-Reactive Protein (CRP) levels at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Neutrophils count at baseline and after the intervention
In a quantitative laboratory method
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start30 Apr 2023
- Primary completion21 Aug 2023
- Study completion21 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryoush Hamidi Alamdari, PhD, Mashhad University of Medical Sciences
- Investigators
- Daryoush Hamidi Alamdari, Ph.D, Principal investigator, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850611
- Sponsor's protocol ID
- IRCT20191228045924N3
- Status last verified
- Oct 2023
- First submitted
- 6 Mar 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data related to the project after the unidentifiable people will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05850611
- Acronym / sponsor ID
- IRCT20191228045924N3
- Conditions
- Diabetic Foot Ulcers, Diabetic Wound
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, DFU, Methylene blue, Non-healing Diabetic Foot Ulcers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Sep 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue | Experimental | Drug: Methylene BlueThe 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. |
| Milk (control) | Experimental | Other: Milk (control)Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks. |
| Methylene Blue and Platelet-Rich Plasma-Fibrin Glue | Experimental | Drug: Methylene Blue and Platelet-Rich Plasma-Fibrin GluePatients 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. |
| Milk and Platelet-Rich Plasma-Fibrin Glue (control) | Experimental | Other: Milk and Platelet-Rich Plasma-Fibrin Glue (control)Patients with non-healing Diabetic Foot Ulcers will be treated with PRP-Fibrin-Glue and 200 ml of milk for 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAlso: Methylthioninium chlorideThe first intervention group includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention for 4 weeks. | Drug | Methylene Blue |
| Milk (control)Also: PlaceboGroup B will receive 200 ml of milk for 4 weeks. | Other | Milk (control) |
| Methylene Blue and Platelet-Rich Plasma-Fibrin GlueAlso: Methylthioninium chloride and PRP-Fibrin GlueGroup C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue. | Drug | Methylene Blue and Platelet-Rich Plasma-Fibrin Glue |
| Milk and Platelet-Rich Plasma-Fibrin Glue (control)Also: PlaceboGroup D will be treated only with fibrin glue and 200 ml of milk for 4 weeks. | Other | Milk and Platelet-Rich Plasma-Fibrin Glue (control) |
Primary outcome
The healing rate of the ulcer
Time frame: 4 weeks
Measurement of wound area with a ruler
Wound Size
Time frame: 4 weeks
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.
33 secondary outcomes
TcPO2 at baseline and after the intervention
Time frame: 4 weeks
Oxygen saturation at baseline and after the intervention
Time frame: 4 weeks
Blood pressure (systolic and diastolic)
Time frame: 4 weeks
The resting systolic toe pressure (TP) at baseline and after the intervention
Time frame: 4 weeks
Serum IL-1β levels at baseline and after the intervention
Time frame: 4 weeks
Serum MCP-1 levels at baseline and after the intervention
Time frame: 4 weeks
Serum TNF-α levels at baseline and after the intervention
Time frame: 4 weeks
Serum IL-6 levels at baseline and after the intervention
Time frame: 4 weeks
Serum HIF-1α levels at baseline and after the intervention
Time frame: 4 weeks
Serum FBS levels at baseline and after the intervention
Time frame: 4 weeks
Serum Insulin levels at baseline and after the intervention
Time frame: 4 weeks
Lipid Profile at baseline and after the intervention
Time frame: 4 weeks
Serum Urea at baseline and after the intervention
Time frame: 4 weeks
Serum Creatinine at baseline and after the intervention
Time frame: 4 weeks
Serum total bilirubin at baseline and after the intervention
Time frame: 4 weeks
Serum Vitamin D levels at baseline and after the intervention
Time frame: 4 weeks
HbA1c at baseline and after the intervention
Time frame: 4 weeks
Serum Albumin (Alb) levels at baseline and after the intervention
Time frame: 4 weeks
Uric Acid levels at baseline and after the intervention
Time frame: 4 weeks
Serum Homocysteine levels at baseline and after the intervention
Time frame: 4 weeks
Serum ALT (alanine transaminase) levels at baseline and after the intervention
Time frame: 4 weeks
Serum AST (Aspartate Transferase) levels at baseline and after the intervention
Time frame: 4 weeks
Serum ALP (alkaline phosphatase) levels at baseline and after the intervention
Time frame: 4 weeks
Serum Met Hemoglobin levels at baseline and after the intervention
Time frame: 4 weeks
Serum Hemoglobin (Hgb, Hb) levels at baseline and after the intervention
Time frame: 4 weeks
Serum white blood cells (WBCs) levels at baseline and after the intervention
Time frame: 4 weeks
Serum total Lymphocyte levels at baseline and after the intervention
Time frame: 4 weeks
Platelet count at baseline and after the intervention
Time frame: 4 weeks
Nitric oxide blood at baseline and after the intervention
Time frame: 4 weeks
Serum lactate dehydrogenase (LDH) levels at baseline and after the intervention
Time frame: 4 weeks
Serum Erythrocyte Sedimentation Rate (ESR) levels at baseline and after the intervention
Time frame: 4 weeks
Serum C-Reactive Protein (CRP) levels at baseline and after the intervention
Time frame: 4 weeks
Neutrophils count at baseline and after the intervention
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Yes. All data related to the project after the unidentifiable people will be shared.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryoush Hamidi Alamdari, Ph.D principal investigator
Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylene Blue and Methylene Blue and Platelet-Rich Plasma-Fibrin Glue in people with Diabetic Foot Ulcers and Diabetic Wound, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daryoush Hamidi Alamdari, Ph.D (+98 51 3882 8574, hamidiad@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healing rate of the ulcer (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.