Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers
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
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2019
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedSeptember 25, 2019
September 1, 2019
2 months
September 18, 2019
September 22, 2019
Conditions
Outcome Measures
Primary Outcomes (10)
Changes of Healing Rate at 1 Week
Measured by difference of granulation index by ImageJ
Changes from baseline of granulation index at 1 week
Changes of Healing Rate at 2 Week
Measured by difference of granulation index by ImageJ
Changes from baseline of granulation index at 2 weeks
Changes of Healing Rate at 3 Week
Measured by difference of granulation index by ImageJ
Changes from baseline of granulation index at 3 weeks
Changes of Healing Rate at 4 Week
Measured by difference of granulation index by ImageJ
Changes from baseline of granulation index at 4 weeks
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
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
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
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
Changes of Inflammation Marker at 2 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Changes from baseline at the end of second week
Changes of Inflammation Marker at 3 Week
Measured by the concentrations of IL-α and TNF-α by ELISA
Changes from baseline at the end of third week
Study Arms (2)
Treatment
EXPERIMENTAL0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
Placebo
PLACEBO COMPARATORPlacebo cream, administered twice a week for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
RS Persahabatan
Jakarta, DKI Jakarta, 13230, Indonesia
RS Pusat Angkatan Darat Gatot Soebroto
Jakarta Pusat, DKI Jakarta, 10410, Indonesia
RSUPN dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Related Publications (1)
Miranda E, Bramono K, Yunir E, Reksodiputro MH, Suwarsa O, Rengganis I, Harahap AR, Subekti D, Suwarto S, Hayun H, Bardosono S, Baskoro JC. Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial. Arch Dermatol Res. 2023 Nov;315(9):2623-2633. doi: 10.1007/s00403-023-02657-8. Epub 2023 Jul 22.
PMID: 37480520DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliza Miranda, MD
Fakultas Kedokteran Universitas Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff of Tropical Infection Division, Department of Dermatology and Venereology
Study Record Dates
First Submitted
September 18, 2019
First Posted
September 23, 2019
Study Start
October 1, 2019
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
September 25, 2019
Record last verified: 2019-09