The investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism.
OBJECTIVE- Infection is associated with poor healing of diabetic lower limb ulcer. Diabetic lower limb ulcer are often lower extremity vascular stenosis or occlusion, poor blood supply, making local ulcer local antibacterial drugs difficult to effectively reach and distribution, resulting in systemic antibacterial efficacy is limited, and easy to induce bacterial resistance at the same time . In recent years, the incidence of clinical multidrug-resistant bacteria increased, increasing the difficulty and cost of treatment. The current study attempts to identify whether the photodynamic therapy (PDT) would kill the surface of ulcer bacteria and promote ulcer healing, and explore the mechanism of methylene blue-mediated photodynamic therapy for diabetic lower limb ulcer RESEARCH DESIGN AND METHODS-This study evaluated six clinical indicators： diabetic foot ulcer area reduction rate, inflammation control rate, Local bacterial load, the dose and use time of antibiotics, adverse reaction rate, bacterial biofilm,local neutrophil extracellular traps. The efficacy and safety of PDT could be confirmed if the clinical indicators of PDT group is better than the control group. In this study, three methods were used to investigate the mechanism of -methylene blue mediated photodynamic therapy for diabetic lower limb ulcer: a comparison of the bacterial load, bacterial biofilm,local neutrophil extracellular traps of the ulcer immediately pre-treatment and immediately,1-week ,2 week,1 momth post-treatment ; EXPECTED RESULTS-The investigators will expect that methylene blue-mediated photodynamic therapy could kill bacteria on the surface of diabetic lower limb ulcer and accelerate wound healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChange from baseline （Ulcer area）in the diabetic lower limb ulcer at day 7
Changes of ulcer area before and after treatment
Time frame: Baseline and day 7
Change from baseline (immediately before the first treatment) in the bacterial load of the ulcer at one hour (immediately after the first treatment)
Changes of local bacterial load before and after treatment
Time frame: Baseline and (immediately after the first treatment)，day 7,14,21,28
Change from baseline(bacterial biofilm）
Changes of local bacterial biofilm before and after treatment
Time frame: Baseline and day 7,14,21,28
The dose of antibiotics
Dosage of antibiotics during treatment
Time frame: 7 days during treatment
The time of antibiotics
Antibiotic use time during treatment
Time frame: 7 days during treatment
Adverse events
including pain,redness, and swelling
Time frame: 7 days during treatment
A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment
Fluorescence intensity and area of local NET
Time frame: Baseline and day 7,14,21,28
Inflammation control rate
Duration of inflammation
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Time frame: 7 days during treatment