Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers
NCT ID: NCT04098562
Last Updated: 2019-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2019-10-31
2020-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
LL37
cream
Standard Wound Care
Standard wound debridement
Placebo
Placebo cream, administered twice a week for 4 weeks
Standard Wound Care
Standard wound debridement
Interventions
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LL37
cream
Standard Wound Care
Standard wound debridement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Eliza Miranda, MD
Staff of Tropical Infection Division, Department of Dermatology and Venereology
Principal Investigators
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Eliza Miranda, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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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, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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19-09-1128
Identifier Type: -
Identifier Source: org_study_id
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