Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetic Foot Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LL37 | Drug | — | UNRESOLVED |
| Standard Wound Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
- interventionNames
- Drug: LL37
- Procedure: Standard Wound Care
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo cream, administered twice a week for 4 weeks
- interventionNames
- Procedure: Standard Wound Care
Primary outcomes (10)
- measure
- Changes of Healing Rate at 1 Week
- timeFrame
- Changes from baseline of granulation index at 1 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMiranda 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 37480520