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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012694
Receipt No. R000014452
Scientific Title Total Contact Cast for intractable foot ulceration in diabetic patients Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
Date of disclosure of the study information 2014/01/01
Last modified on 2014/05/27

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Basic information
Public title Total Contact Cast for intractable foot ulceration in diabetic patients
Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
Acronym Total Contact Cast for intractable foot ulceration in diabetic patients
Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
Scientific Title Total Contact Cast for intractable foot ulceration in diabetic patients
Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
Scientific Title:Acronym Total Contact Cast for intractable foot ulceration in diabetic patients
Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
Region
Japan

Condition
Condition Non-healing Foot Ulcer
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of total contact casting in the treatment of non-healing foot ulcers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ulcer Healing (at 12 weeks)
Time required for complete healing
Key secondary outcomes The presence or absence of ulcer occurrence of other sites up to 12 weeks after the operation.
Presence or absence of complications.
Period up to good granulation
Ulcerogenic at other sites.
Occurrence of other complications.
TCC wearing period.
Total cost of care for wound treatment.
Time-dependent change in the total area.

Base
Study type

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 For patients with chronic ulcer on the sole of the foot that can not be healed with standard therapy for over 4 weeks, to immobilize with TCC which spread the pressure on the sole for the avoidance of excessive pressure on specific area, covered up to under the knee.
Procedure of TCC:
1.Cover the affected area with gauzes or wound dressing materials appropriately.
2.Apply felt around the ulcer and/or bony area for protection and non weight- bearing.
3.Mold Total Contact Casting with photocurable or water-curable materials over stockinette and cast pad.
4.Attach the cast heel and/or the cast shoe for walking.
5.Release the TCC once every one or two weeks for observation of the wound. After observation, mold another new TCC.
6.Debridement of the wound is assumed to be performed as necessary.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Chronic ulcers in the plantar area.
2.Ambulatory patient
3.Debridement has been done in the presence of necrotic tissue and/or infection.
4.Ulcers with a small or moderate amount of discharge.
5.To be performed with the principle of consent, given in writing, by the person himself. However, if the document of consent from the person cannot be obtained for any reason, a legal representative (legal representative of the person being treated) agrees to allow the procedure(s)
Key exclusion criteria 1.Presence of ulcers in both the forefoot and the heel.
2.Local infection on the ulcer area and/or systemic infection.
3.In the case of bone exposure or radiographic signs of myelitis.findings.
4.Negative arterial Doppler examination for the dorsalis pedis artery and/or the posterior tibial artery due to critical limb ischemia.
5.Plantar ulcers exist bilaterally or the contralateral foot has been amputated.
6.Malignant tumor exists in the wound bed or its surroundings.
7.Uncontrollable bleeding from the wound.
8.Deep venous thrombosis, varicose veins, or lymphedema.
9.Radiation therapy, chemotherapy, VEGF inhibitor, or administration of steroids.
10.Poor general status, under-nutrition, coagulopathy, or connective tissue disease.
11.A pregnant or breast-feeding woman or a child.
12.Patients who cannot come to our hospital.
13.Patients judged to be inappropriate for enrollment in this study.



Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamoru Kikuchi
Organization Saga University Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Nabeshima 5-1-1, Saga-city, Saga, Japan
TEL 0952-34-2460
Email mamoru-osk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Kikuchi
Organization Saga University Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Nabeshima 5-1-1, Saga-city, Saga, Japan
TEL 0952-34-2460
Homepage URL
Email mamoru-osk@umin.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization Saga University Hospital
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
Address
Tel
Email

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
2014 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 25 Day
Last modified on
2014 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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