Chronic skin ulcer
Conditions
Interventions
Intervention type:DRUG,DEVICE
Name of intervention:Treatment of bFGF with negative wound pressure therapy
Dose form / Japanese Medical Device Nomenclature:SPRAY
Route of administration / Site of appli
Sponsors
Masahiro Tachi
Densou Hayashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with non-healing skin ulcer despite of standard treatment for more than 3 weeks 2. Patients with pressure ulcers, diabetic skin ulcers, periphera arterial diseases, venous stasis ulcers or open surgical wounds 3. Age is between 20 and 80. 4. Patients providing written informed consents 5. Patients with full thickness wounds without exposing bones or joints 6. Maximun wound area is within 200 squarecentimeter.
Exclusion criteria
Exclusion criteria: 1. Ulcer with local infectious sign 2. Patients with a history of deep vein thrombosis 3. Patients under other clinical trial 4. Patients with ulcers which is difficult to measure, or who denies wound evaluation 5. Patients with ischemic leg ulcer (demonstrated by ABI less than 0.7 or skin perfusion pressure less than 40 mmHg 6. Pregnant patients or those who may be pregnant before the end of the study 7. Skin ulcer with malignancy or a history of malignancy 8. Patients with a history of allergic reactions to bFGF 9. Ulcers with untreated osteomyelitis, necrotic tissues or exposed vessels or vital organs 10. Patients with malignant tumor or diabetic proliferating retinopathy 11. Patient for whom this clinical trial is jugged to be inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound reduction rate per week | — |
Secondary
| Measure | Time frame |
|---|---|
| wound depth, area of granulation tissue, pain assessment | — |
Countries
Japan
Contacts
Public ContactMasahiro Tachi
Graduate School of Medicine Tohoku University
Outcome results
None listed