Trial · Interventional

Status unknownPhase 2Registry data

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

NCTNCT04098562Other id19-09-1128

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 2
Enrollment: 40 participants (estimated)
Sponsor: Fakultas Kedokteran Universitas Indonesia · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Indonesia
Start: Oct 2019 (estimated)
Primary completion: Dec 2019 (estimated)
Completion: Jan 2020 (estimated)
First posted: 23 Sept 2019
Last update posted: 25 Sept 2019
Conditions: Diabetic Foot Ulcer

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph 2
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers
NCT04098562
est. Oct 2019 to est. Jan 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

LL37Drug
Standard Wound CareProcedure

Arms2

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

Primary outcomes10

Outcomes the sponsor listed as primary.

Changes of Healing Rate at 1 Week
Time frame · Changes from baseline of granulation index at 1 week
Registry description
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 2 Week
Time frame · Changes from baseline of granulation index at 2 weeks
Registry description
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 3 Week
Time frame · Changes from baseline of granulation index at 3 weeks
Registry description
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 4 Week
Time frame · Changes from baseline of granulation index at 4 weeks
Registry description
Measured by difference of granulation index by ImageJ
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
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
Registry description
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
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
Registry description
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
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
Registry description
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
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
Registry description
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
Time frame · Changes from baseline at the end of second week
Registry description
Measured by the concentrations of IL-α and TNF-α by ELISA
Changes of Inflammation Marker at 3 Week
Time frame · Changes from baseline at the end of third week
Registry description
Measured by the concentrations of IL-α and TNF-α by ELISA

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial.

Miranda et al. 2023Archives of dermatological researchcited by 27

PMID 37480520PMC10514151DOI 10.1007/s00403-023-02657-8PUB-37480520

CC BY5 results

Download PDF See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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