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LL-37

Cathelicidin, hCAP-18, FALL-39, CAP-18

Quick Stats
Studies 2230
Trials 95
Unknown PHASE2 INTERVENTIONAL NCT04098562

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

Name: LL37
Type: DRUG
Description: cream
Name: Standard Wound Care
Type: PROCEDURE
Description: Standard wound debridement

Primary Outcomes

Measure: Changes of Healing Rate at 1 Week
TimeFrame: Changes from baseline of granulation index at 1 week
Description: Measured by difference of granulation index by ImageJ
Measure: Changes of Healing Rate at 2 Week
TimeFrame: Changes from baseline of granulation index at 2 weeks
Description: Measured by difference of granulation index by ImageJ
Measure: Changes of Healing Rate at 3 Week
TimeFrame: Changes from baseline of granulation index at 3 weeks
Description: Measured by difference of granulation index by ImageJ
Measure: Changes of Healing Rate at 4 Week
TimeFrame: Changes from baseline of granulation index at 4 weeks
Description: Measured by difference of granulation index by ImageJ
Measure: Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
TimeFrame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week
Description: Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measure: Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week
TimeFrame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week
Description: Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measure: Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week
TimeFrame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week
Description: Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measure: Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week
TimeFrame: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week
Description: Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Measure: Changes of Inflammation Marker at 2 Week
TimeFrame: Changes from baseline at the end of second week
Description: Measured by the concentrations of IL-α and TNF-α by ELISA
Measure: Changes of Inflammation Marker at 3 Week
TimeFrame: Changes from baseline at the end of third week
Description: Measured by the concentrations of IL-α and TNF-α by ELISA

Trial Information

NCT ID

NCT04098562

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Fakultas Kedokteran Universitas Indonesia

Last Updated

December 15, 2025