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

Early Phase 1UnknownNCT05850611

Mashhad University of Medical Sciences20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Foot Ulcers Diabetic Wound

Interventions

Methylene BlueDRUG

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

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

Methylene Blue and Platelet-Rich Plasma-Fibrin GlueDRUG

Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central 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

Data from ClinicalTrials.gov

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