PENGARUH PEMBERIAN GEL POLIPEPTIDA TOPIKAL TERHADAP PERUBAHAN UKURAN ULKUS DIABETIKUM
| 1. Background | |
|---|---|
| Registration Number | INA-2Y49T46A |
| Date of registry approval | 04-08-2025 |
| Registration Date | 03-08-2025 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | PENGARUH PEMBERIAN GEL POLIPEPTIDA TOPIKAL TERHADAP PERUBAHAN UKURAN ULKUS DIABETIKUM |
| Public (popular study title) | PENGARUH PEMBERIAN GEL POLIPEPTIDA TOPIKAL TERHADAP PERUBAHAN UKURAN ULKUS DIABETIKUM |
| 2. Sponsor and Funding | |
| Primary Sponsor | The main researcher is the individual sponsor of the study |
| Source(s) of monetary or material support | Dermatology and Venereology Department of Sebelas Maret University/ Dr. Moewardi General Hospital, Surakarta |
| Other partners | Not Specified |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Dr. dr. Suci widhiati, M.Sc., Sp.DVE, Subsp. DA |
| City | Surakarta |
| Country | Indonesia |
| Principal investigator's affiliation | Dermatology and Venereology Department of Sebelas Maret University/ Dr. Moewardi General Hospital, Surakarta |
| Principal Investigator's email address | suci_riza@yahoo.com |
| Public Queries | |
| Contact person name for public queries | dr. Stella Gracia Octarica |
| Address for public queries | Department of Dermatology and Venereology, Dr. Moewardi General Hospital, Jl. Kolonel Sutarto No.132, Jebres, Kec. Jebres, Kota Surakarta, Jawa Tengah 57126 |
| City | Surakarta |
| Country | Indonesia |
| ZIP | 57126 |
| Affiliation for public queries | Dermatology and Venereology Department of Sebelas Maret University/ Dr. Moewardi General Hospital, Surakarta |
| Email address for public queries | stellagracia_o@yahoo.com |
| Phone number for public queries | +6281392771790 |
| Scientific Queries | |
| Name of Contact for scientific queries | dr. Stella Gracia Octarica |
| Address for scientific queries | Department of Dermatology and Venereology, Dr. Moewardi General Hospital, Jl. Kolonel Sutarto No.132, Jebres, Kec. Jebres, Kota Surakarta, Jawa Tengah 57126 |
| City | Surakarta |
| Country | Indonesia |
| ZIP | 57126 |
| Affiliation of scientific queries contact | Dermatology and Venereology Department of Sebelas Maret University/ Dr. Moewardi General Hospital, Surakarta |
| Email address for scientific queries | stellagracia_o@yahoo.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | 1.920 /VI/ HREC /2024 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan RSUD Dr. Moewardi |
| Date of Ethic approval | 06-08-2024 |
| Contact details of Ethic Committee (phone, email, and office) | Komite Etik Penelitian Kesehatan RSUD Dr. Moewardi (0271) 634634 ext 525 085647160979 |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | Not applicable |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Surakarta |
| Recruitment status | Initial |
| Date of first enrollment | 22-01-2025 |
| Targeted Sample size | 00026 - |
| Number of enrolled participants | 26 |
| Date of study completion (last participant, last visit) | |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Diabetic ulcer |
| Purpose of the study | Supportive care |
| Study type | Interventional |
| Interventional Study category | Clinical trial |
| Study phase | Phase 1 |
| Method of allocation | Randomized allocation |
| Description of the allocation concealment mechanism and sequence generation | Pasien di randomisasi dengan tabel randomisasi dan di berikan terapi secara blinding, dibagi menjadi 2 kelompok, kelompok kontrol dan perlakuan, dimana Penelitian juga tidak mengetahui isi dari obat yang diberikan kepada pasien. |
| Masking | Pasien dan Peneliti |
| Study intervention (study arm) | Pemberian Gel polipeptida 7% secara topikal untuk ulkus diabetikum |
| Control intervention (control arm) | Pemberian gel duoderm hydroactive gel |
| Intervention assignment | Single arm |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 18 |
| Maximum age | Not Specified |
| Inclusion criteria | Pasien berusia >18 tahun
Pasien dengan ulkus diabetikum derajat I-IV |
| Exclusion criteria | Pasien yang memiliki alergi terhadap bahan
Pasien yang sudah mendapatkan terapi lain pasien yang menolak mengikuti penelitian |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Perubahan luas permukaan ulkus diabetikum |
| Metric/method of measurement | Dokumentasi dengan kamera dan analisa dengan ImageJ |
| Timepoint(s) of measurement | Pada Hari kedatangan ke 0, 7, 14, dan hari ke 21 |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | Usia
Jenis kelamin Indeks massa tubuh Jenis Diabetes Komorbid Derajat Ulkus Bakteri Penyulit Lokasi Ulkus |
| Adverse events | |
| Outcome measures | |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | Undecided |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |