Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Criteria

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