臨床研究等提出・公開システム

Japan-German Collaborative Study for developing Evidence-based Treatment Guideline on Complicated Diabetic Foot (J-GDF Study)

Japan-German Collaborative Study for developing Evidence-based Treatment Guideline on Complicated Diabetic Foot

Shigeo Kono, MD, PhD

National Hospital Organization Kyoto Medical Center

1-1 Fukakusa Mukaihata-cho Fushimi-ku, Kyoto

skono@kyotolan.hosp.go.jp

Shigeo Kono, MD, PhD

National Hospital Organization Kyoto Medical Center

1-1 Fukakusa Mukaihata-cho Fushimi-ku, Kyoto

+81-75-641-9161

skono@kyotolan.hosp.go.jp

RECRUITING

April. 01, 2014

Observational

International multicenter observational study

open(masking not used)

No

N/A

-Patients with type I or II Diabetes
-Patients has an ulcer, gangrene and/or charcot
-Patients who signed written consent

-Patients with vital prognosis less than a year
-Patients whom his/her primary physician determined that
he/she is inappropriate as a candidate for this study

Both

Diabetic Foot

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

The rate of primary healing and amputation

Duration of hospitalization, Severity of diabetic foot, resolution of infection, pathogens, antibiotic use (duration and type), vascular intervention (Endovascular or bypass), off-loading, QOL, the rate of recurrence, employment status (the rate of unemployment), the mode of nursing, and cardiovascular events.

Mar. 04, 2014