Diabetic Extremity Lower Ulcers Clinical Trial
Official title:
Efficacy and Safety of Methylene Blue -Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer : a Randomized Controlled Study
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.
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