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

Diabetic Foot Ulcer Clinical Trial

Official title:

The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04098562
• Other study ID #: 19-09-1128
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2019
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Eliza Miranda, MD
• Phone: +628119001018
• Email: elisamiranda74[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Inflammation
• Ulcer

Intervention

Drug:
• LL37
cream

Procedure:
• Standard Wound Care
Standard wound debridement

Locations

Country	Name	City	State
Indonesia	RS Persahabatan	Jakarta	DKI Jakarta
Indonesia	RS Pusat Angkatan Darat Gatot Soebroto	Jakarta Pusat	DKI Jakarta
Indonesia	RSUPN dr. Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

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