Diabetic Foot Ulcer
Conditions
Brief summary
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.
Interventions
DRUGLL37
cream
PROCEDUREStandard Wound Care
Standard wound debridement
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with DFU * Ankle brachial index (ABI) 0.9 - 1.3 * Wound area 5 - 20 cm\^2 * Wound depth until subcutaneous tissue * Without systemic infection, osteomyelitis, septic arthritis, or fasciitis * Subjects are willing to participate by signing consent
Exclusion criteria
* Gangrene * On treatment with systemic corticosteroids within 7 days before the start of study * On treatment with systemic antibiotics within 2 days before the start of study * Patients with end stage renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Healing Rate at 1 Week | Changes from baseline of granulation index at 1 week | Measured by difference of granulation index by ImageJ |
| Changes of Healing Rate at 2 Week | Changes from baseline of granulation index at 2 weeks | Measured by difference of granulation index by ImageJ |
| Changes of Healing Rate at 3 Week | Changes from baseline of granulation index at 3 weeks | Measured by difference of granulation index by ImageJ |
| Changes of Healing Rate at 4 Week | Changes from baseline of granulation index at 4 weeks | Measured by difference of granulation index by ImageJ |
| Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week | Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week | Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab |
| Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week | Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week | Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab |
| Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week | Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week | Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab |
| Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week | Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week | Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab |
| Changes of Inflammation Marker at 2 Week | Changes from baseline at the end of second week | Measured by the concentrations of IL-α and TNF-α by ELISA |
| Changes of Inflammation Marker at 3 Week | Changes from baseline at the end of third week | Measured by the concentrations of IL-α and TNF-α by ELISA |
Countries
Indonesia
Contacts
Primary ContactEliza Miranda, MD
Outcome results
None listed