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

University of Indonesia (UI)

Status and phase: Unknown; Phase 2

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: Standard Wound Care; Drug: LL37

Study type: Interventional

Funder types: Other

Identifiers

NCT04098562

19-09-1128

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks

Treatment:

Drug: LL37

Procedure: Standard Wound Care

Placebo

Placebo Comparator group

Description:

Placebo cream, administered twice a week for 4 weeks

Treatment:

Procedure: Standard Wound Care