UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012694 |
|---|---|
| Receipt number | 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 17:58:42 |
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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
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
mamoru-osk@umin.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014452
