UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039659 |
|---|---|
| Receipt number | R000045151 |
| Scientific Title | Clinical research of neurolysis in diabetic foot neuropathy |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2020/03/02 14:21:26 |
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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
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
keisei.saga@gmail.com
Sponsor or person
Institute
Saga University Hospital Plastic surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045151
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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