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

NCT05850611 | Unknown Early Phase 1

• 1 other identifier: IRCT20191228045924N3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcers; Diabetic Wound

Keywords

Platelet-Rich Plasma-Fibrin Glue; DFU; Methylene blue; Non-healing Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (2)

• The healing rate of the ulcer

  Measurement of wound area with a ruler

  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.

  4 weeks

Secondary Outcomes (33)

• TcPO2 at baseline and after the intervention

  4 weeks

• Oxygen saturation at baseline and after the intervention

  4 weeks

• Blood pressure (systolic and diastolic)

  4 weeks

• The resting systolic toe pressure (TP) at baseline and after the intervention

  4 weeks

• Serum IL-1β levels at baseline and after the intervention

  4 weeks

Study Arms (4)

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.

Drug: Methylene Blue

Milk (control)

EXPERIMENTAL

Patients with non-healing Diabetic Foot Ulcers only will receive 200 ml of milk for 4 weeks.

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.

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.

Other: Milk and Platelet-Rich Plasma-Fibrin Glue (control)

Interventions

Methylene Blue DRUG

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

Methylene Blue

Milk (control) OTHER

Group B will receive 200 ml of milk for 4 weeks.

Also known as: Placebo

Milk (control)

Methylene Blue and Platelet-Rich Plasma-Fibrin Glue DRUG

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

Methylene Blue and Platelet-Rich Plasma-Fibrin Glue

Milk and Platelet-Rich Plasma-Fibrin Glue (control) OTHER

Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks.

Also known as: Placebo

Milk and Platelet-Rich Plasma-Fibrin Glue (control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, 99191-91778, Iran

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Methylene Blue; Milk

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Daryoush Hamidi Alamdari, Ph.D

  Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daryoush Hamidi Alamdari, Ph.D

CONTACT

+98 51 3882 8574; hamidiad@mums.ac.ir

Elaheh Emadi, Ph.D

CONTACT

+98 9355850931; EmadiE4001@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 9, 2023
• Study Start: April 30, 2023
• Primary Completion: August 21, 2023
• Study Completion: September 21, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

IR (1)