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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks |
|
| Placebo | Placebo Comparator | Placebo cream, administered twice a week for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LL37 | Drug | cream |
| |
| Standard Wound Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eliza Miranda, MD | Contact | +628119001018 | elisamiranda74@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Eliza Miranda, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RS Persahabatan | Jakarta | DKI Jakarta | 13230 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37480520 | Derived | 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. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Procedure |
Standard wound debridement |
|
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 |
| RS Pusat Angkatan Darat Gatot Soebroto | Jakarta Pusat | DKI Jakarta | 10410 | Indonesia |
|
| RSUPN dr. Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |