Back to results

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

Primary Purpose

Diabetic Foot Ulcer

Status

Unknown status

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

LL37

Standard Wound Care

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

RS Pusat Angkatan Darat Gatot Soebroto
RSUPN dr. Cipto Mangunkusumo
RS Persahabatan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

Placebo cream, administered twice a week for 4 weeks

Outcomes

Primary Outcome Measures

Changes of Healing Rate at 1 Week

Measured by difference of granulation index by ImageJ

Changes of Healing Rate at 2 Week

Measured by difference of granulation index by ImageJ

Changes of Healing Rate at 3 Week

Measured by difference of granulation index by ImageJ

Changes of Healing Rate at 4 Week

Measured by difference of granulation index by ImageJ

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 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 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 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 of Inflammation Marker at 2 Week

Measured by the concentrations of IL-α and TNF-α by ELISA

Changes of Inflammation Marker at 3 Week

Measured by the concentrations of IL-α and TNF-α by ELISA

Secondary Outcome Measures

Full Information

NCT ID

NCT04098562

First Posted

September 18, 2019

Last Updated

September 22, 2019

Sponsor

Fakultas Kedokteran Universitas Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT04098562

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo cream, administered twice a week for 4 weeks

Intervention Type

Drug

Intervention Name(s)

LL37

Intervention Description

cream

Intervention Type

Procedure

Intervention Name(s)

Standard Wound Care

Intervention Description

Standard wound debridement

Primary Outcome Measure Information:

Title

Changes of Healing Rate at 1 Week

Description

Measured by difference of granulation index by ImageJ

Time Frame

Changes from baseline of granulation index at 1 week

Title

Changes of Healing Rate at 2 Week

Description

Measured by difference of granulation index by ImageJ

Time Frame

Changes from baseline of granulation index at 2 weeks

Title

Changes of Healing Rate at 3 Week

Description

Measured by difference of granulation index by ImageJ

Time Frame

Changes from baseline of granulation index at 3 weeks

Title

Changes of Healing Rate at 4 Week

Description

Measured by difference of granulation index by ImageJ

Time Frame

Changes from baseline of granulation index at 4 weeks

Title

Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week

Description

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Time Frame

Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week

Title

Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week

Description

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Time Frame

Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week

Title

Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week

Description

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Time Frame

Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week

Title

Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week

Description

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Time Frame

Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week

Title

Changes of Inflammation Marker at 2 Week

Description

Measured by the concentrations of IL-α and TNF-α by ELISA

Time Frame

Changes from baseline at the end of second week

Title

Changes of Inflammation Marker at 3 Week

Description

Measured by the concentrations of IL-α and TNF-α by ELISA

Time Frame

Changes from baseline at the end of third week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eliza Miranda, MD

Phone

+628119001018

elisamiranda74@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

RS Pusat Angkatan Darat Gatot Soebroto

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10410

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

Phone

+628119001018

elisamiranda74@yahoo.com

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

First Name & Middle Initial & Last Name & Degree

Luddwi A Rizky, MD

Facility Name

RSUPN dr. Cipto Mangunkusumo

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

Phone

+628119001018

elisamiranda74@yahoo.com

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

First Name & Middle Initial & Last Name & Degree

Luddwi A Rizky, MD

Facility Name

RS Persahabatan

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

13230

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

Phone

+628119001018

elisamiranda74@yahoo.com

First Name & Middle Initial & Last Name & Degree

Eliza Miranda, MD

First Name & Middle Initial & Last Name & Degree

Luddwi A Rizky, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs