Diabetic Foot Ulcer Clinical Trial
Official title:
The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of
6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound
debridement, infection control, pressure relief and revascularization are main pillars of DFU
management. Various substances and modalities are being investigated for their potential
effects in treating DFU, one of which is LL-37.
In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled.
Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream
(treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound
care. The primary outcomes are the healing rate measured by wound area and granulation index
and changes in patterns of aerobic bacteria colonization during the 4-week study duration and
changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the
second and third week of study compared to baseline.
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