Clinical trial NCT04098562: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes of Healing Rate at 1 Week
timeFrame: Changes from baseline of granulation index at 1 week
measure: Changes of Healing Rate at 2 Week
timeFrame: Changes from baseline of granulation index at 2 weeks
measure: Changes of Healing Rate at 3 Week
timeFrame: Changes from baseline of granulation index at 3 weeks
measure: Changes of Healing Rate at 4 Week
timeFrame: Changes from baseline of granulation index at 4 weeks
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
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
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
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
measure: Changes of Inflammation Marker at 2 Week
timeFrame: Changes from baseline at the end of second week
measure: Changes of Inflammation Marker at 3 Week
timeFrame: Changes from baseline at the end of third week
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RS Pusat Angkatan Darat Gatot Soebroto
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: RS Persahabatan
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Eliza Miranda, MD
role: PRINCIPAL_INVESTIGATOR
References: