Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1)

UMIN ID: UMIN000000831

Registered date:21/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diabetic ulcer
• Date of first enrollment: 2004/10/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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: 0 micro gram of trafermin. once a day for 8 weeks.

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: KAKEN PHARMACEUTICAL CO., LTD.
• Source(s) of Monetary Support: KAKEN PHARMACEUTICAL CO., LTD.