A Phase 2 interventional study of LL37 and Standard Wound Care in Diabetic Foot Ulcer, sponsored by Fakultas Kedokteran Universitas Indonesia. Status unknown at 3 sites in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Phase 2, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
Drug: LL37 · Procedure: Standard Wound Care
Placebo cream, administered twice a week for 4 weeks
Procedure: Standard Wound Care
cream
Standard wound debridement
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Fakultas Kedokteran Universitas Indonesia