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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
cream
Standard wound debridement
RS Persahabatan
Jakarta, DKI Jakarta, Indonesia
RS Pusat Angkatan Darat Gatot Soebroto
Jakarta Pusat, DKI Jakarta, Indonesia
RSUPN dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
Changes of Healing Rate at 1 Week
Measured by difference of granulation index by ImageJ
Time frame: Changes from baseline of granulation index at 1 week
Changes of Healing Rate at 2 Week
Measured by difference of granulation index by ImageJ
Time frame: Changes from baseline of granulation index at 2 weeks
Changes of Healing Rate at 3 Week
Measured by difference of granulation index by ImageJ
Time frame: Changes from baseline of granulation index at 3 weeks
Changes of Healing Rate at 4 Week
Measured by difference of granulation index by ImageJ
Time frame: Changes from baseline of granulation index at 4 weeks
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Time frame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week
Changes of Inflammation Marker at 2 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Time frame: Changes from baseline at the end of second week
Changes of Inflammation Marker at 3 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Time frame: Changes from baseline at the end of third week
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