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

Phase 2

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Standard Wound Care; Drug: LL37

• Registration Number: NCT04098562
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-22
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-25
• Study Start: 2019-10
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Standard Wound Care	Placebo cream, administered twice a week for 4 weeks
Treatment	Standard Wound Care	0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
Treatment	LL37	0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (3)

RS Pusat Angkatan Darat Gatot Soebroto; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

RSUPN dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

RS Persahabatan; 🇮🇩 Jakarta, DKI Jakarta, Indonesia