UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A non-randomized controlled trial examining effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Title of the study (Brief title)	Effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Region	Japan

Condition
Condition	Pressure ulcer
Classification by specialty	Surgery in general Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine and compare the effects of zinc-containing preparation polaprezinc and its subcomponent L-carnosine on the healing of chronic pressure ulcers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in PUSH (Pressure Ulcer Scale for Healing) score
Key secondary outcomes	Body weight, Biochemistry, Dietary intake

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After 4-week untreated period, polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
Interventions/Control_2	Polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
Interventions/Control_3	L-Carnosine is administered orally at a dose of 58 mg twice a day until complete healing or for a maximum of 4 weeks. For patients without complete healing within 4 weeks, from the end of 4-week period, polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet following requirements: 1) aged 20 and older 2) at least one stage 2, 3, or 4 chronic pressure ulcer according to the revised National Pressure Ulcer Advisory Panel (NPUAP) classification system 3) an estimated surface area of one ulcer is 24 square centimeters or less, as calculated with the formula: greatest length (head to toe) multiplied by greatest width (side to side) of the ulcer 4) patients who take a diet orally 5) written informed consent from patients and their families before registration to this study
Key exclusion criteria	1) a clinical suspicion or diagnosis of osteomyelitis 2) diabetes mellitus 3) peripheral vascular disease 4) neoplastic disease 5) acute illness (e.g., infection) 6) other severe diseases 7) patients who receive tube or parenteral feeding 8) use of steroids 9) patients who are in the terminal phase of their illness
Target sample size	42

Research contact person
Name of lead principal investigator	Kensaku Sakae
Organization	The Jikei University School of Medicine
Division name	Department of Public Health and Environmental Medicine
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL	03-3433-1111(ext.2266)
Email	yashiohp@nifty.com

Public contact
Name of contact person	Kensaku Sakae
Organization	The Jikei University School of Medicine
Division name	Department of Public Health and Environmental Medicine
Address	3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL	03-3433-1111(ext.2266)
Homepage URL
Email	yashiohp@nifty.com

Sponsor
Institute	Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人慶榮会　八潮病院　（埼玉県） 特別養護老人ホーム　杜の家やしお　（埼玉県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 12 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 28 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006923