Diabetic ulcer
Conditions
Interventions
KCB-1 0.01% administration group: 30micro gram of trafermin. once a day for 8 weeks.
KCB-1 0.001% administration group: 3 micro gram of trafermin. once a day for 8 weeks.
Placebo administration group:
Sponsors
KAKEN PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) ulcer measuring 900 mm2 or less(Attending physicians selected a target ulcer in the presence of multiple ulcers.) (2) age: =>20 (3) sex: male and female, setting: hospitalized and outpatient (4) patients providing written informed consent
Exclusion criteria
Exclusion criteria: (1) patients who have a target ulcer with a serious infection (2) patients who have a target ulcer reaching the periosteum (3) patients whose pulsation of the dorsal artery of foot or posterior tibial artery can not be palpable. However, patients are enrolled in this study if the ankle-brachial index at rest is not less than 0.9 in patients with no palpable pulsation of either artery (excluding those with severe calcification due to maintenance hemodialysis or diabetes). (4) patients with bedsores (5) patients with a malignant tumor or a history of a malignant tumor (6) patients with a history of hypersensitivity reactions to KCB-1 (7) patients with other serious comorbid disease (8) patients receiving oral administration or injection of adrenocortical steroids at 20 mg/day or greater doses as prednisolone (9) patients who participated in a clinical study within 6 months prior to this study (10) women with confirmed or suspected pregnancy, nursing women, women who would like to become pregnant during the trial (11) patients having been judged to be ineligible to participate in this study by the attending physicians for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer shrinkage evaluate: Grade 1 achievement {Marked reduction in the ulcer area (at least 75%) or depth (at least 75%) } during 8-week follow-up | — |
Countries
Japan
Outcome results
None listed