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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000002671
Date of registration:	26/10/2009
Prospective Registration:	Yes
Primary sponsor:	Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Public title:	A study of therapeutic angiogenesis in critical limb ischemia using gelatin hydrogel incorporating basic fibroblast growth factor
Scientific title:	A study of therapeutic angiogenesis in critical limb ischemia using gelatin hydrogel incorporating basic fibroblast growth factor - Therapeutic angiogenesis by basic fibroblast growth factor
Date of first enrolment:	2009/12/01
Target sample size:	10
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003251
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Ryuzo Sakata
Address:	54 Shogoin-Kawahara, Sakyo, Kyoto Japan
Telephone:	075-751-3780
Email:
Affiliation:	Kyoto University Graduate School of Medicine Cardiovascular Surgery

Name:
Address:	Japan
Telephone:	075-751-3784
Email:
Affiliation:	Kyoto University Graduate School of Medicine Cardiovascular Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Hemodialysis Active diabetic retinopathy Active malignancy Current smoker Allergy for gelatin

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Arteriosclerosis obliterans Buerger's disease

Intervention(s)

Muscular injection of gelatin hydrogel incorporating basic fibroblast growth factor

Primary Outcome(s)

Transcutanous oxygen tension (TcO2) Adverse events Side effects

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Kyoto University Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	16/08/2012
URL:

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