UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of neurolysis in diabetic foot neuropathy
Acronym	Clinical research of neurolysis in diabetic foot neuropathy
Scientific Title	Clinical research of neurolysis in diabetic foot neuropathy
Scientific Title:Acronym	Clinical research of neurolysis in diabetic foot neuropathy
Region	Japan

Condition
Condition	diabetic foot neuropathy
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The clinical research consists of patients with neuropathy at the tarsal tunnels due to entrapment syndrome. They will be selected from among diabetic patients with sensory nerve disorder such as paresthesia or hypaesthesia in treatment by Uemura, at Plastic Surgery, Saga University Hospital. The projects objective is to ascertain, using the clinical study protocol, the positive effect that neurological compression will have on tarsal tunnel paresthesia caused by entrapment syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Preoperatively the complain of tingling in the affected foot, positive Tinel-like signs, and sensory disturbance and abnormal motor nerve conduction velocity existed in all feet.The modified Toronto Clinical Neuropathy Score (mTCNS) was used to measure changes before and three months after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Surgical technique
Interventions/Control_2
Interventions/Control_3
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	1.The patient had to have symptomatic diabetic neuropathy with clinical signs, such as tingling and touch sensation. 2.The patients took proper care of their feet and want to have the surgery. 3.The patient's neuropathy had to be documented by nerve conduction studies with electrophysiological test results that showed decreased motor nerve conduction velocity before surgery. 4.The patient's diabetes was in good glycemic control. 5.The patients had no arterial deficiency. Patients get informed consent for this surgery. If impossible to be agree by technical problems families get informed consent.
Key exclusion criteria	1. The patients had no treatment of diabetes. 2. The patients had neuropathy of lower extremities due to other spine diseases. 3.The patients had arterial deficiency including Critical limb ischemia. 4.The patients had treatments by radiotherapy, chemotherapy etc. 5.The patients had poor general condition and nutrition. 6.The patients was pregnant woman and child 7. The patients cannot move to clinic to see the doctors. 8.The patients that were excluded by medical problems.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tetsuji Middle name Last name Uemura
Organization	Saga University Hospital
Division name	Plastic surgery
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga city , Saga prefecture ,Japan
TEL	+81-952-34-2460
Email	uemurat@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Tetsuji Middle name Last name Uemura
Organization	Saga University Hospital
Division name	Plastic surgery
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga city , Saga prefecture ,Japan
TEL	+81-952-34-2460
Homepage URL
Email	keisei.saga@gmail.com

Sponsor
Institute	Saga University Hospital Plastic surgery
Institute
Department

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

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

IRB Contact (For public release)
Organization	Saga University
Address	5-1-1 Nabeshima, Saga city , Saga prefecture ,Japan
Tel	+81-952-34-2460
Email	keisei.saga@gmail.com

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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 02 Month 02 Day
Date of IRB	2015 Year 02 Month 02 Day
Anticipated trial start date	2020 Year 03 Month 02 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 02 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045151