UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013225 |
|---|---|
| Receipt number | R000015221 |
| Scientific Title | The study of composite skin grafting over human acellular dermal matrix scaffold for treating diabetic low extremity ulcers |
| Date of disclosure of the study information | 2014/02/22 |
| Last modified on | 2014/02/22 16:25:16 |
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Basic information
Public title
The study of composite skin grafting over human acellular dermal matrix scaffold for treating diabetic low extremity ulcers
Acronym
composite skin grafting for diabetic low extremity ulcers
Scientific Title
The study of composite skin grafting over human acellular dermal matrix scaffold for treating diabetic low extremity ulcers
Scientific Title:Acronym
composite skin grafting for diabetic low extremity ulcers
Region
| Asia(except Japan) |
Condition
Condition
Diabetic low extremity ulcer is one of the refractory wounds and always poses therapeutic challenges.
Classification by specialty
| Dermatology | Plastic surgery | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diabetic low extremity ulcer is one of the refractory wounds and always poses therapeutic challenges. The use of composite razor-thin skin grafting over acellular dermal matrix scaffold has been successful for burns but rarely been reported in treating diabetic low extremity ulcers. Here, we investigated the outcomes of composite razor-thin skin autografting over acellular dermal matrix scaffold on diabetic low extremity ulcers treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patients received a split-thickness autograft combined with ReCell(experimental group)
Interventions/Control_2
patients received split-thickness autograft alone (control group)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged over eighteen years old with a diagnosis of type 1 or type 2 diabetes, who had a diabetic low extremity ulcer last for over four weeks, with a stage 2 by Wagner's scale, and size more than three cm2, absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2) and had indications of skin grafting were eligible for inclusion
Key exclusion criteria
patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease), using corticosteroids or immunosuppressor, a high anesthesiology or surgical risk, uncontrolled hyperglycemia (preoperative HbA1c greater than 12%)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zhicheng Hu |
Organization
The First Affiliated Hospital of Sun Yat-sen University
Division name
Department of Burn Surgery
Zip code
Address
58 Zhongshan Road II, Guangzhou 510080, China
TEL
+86-20-87755766-8235
willway128@163.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zhicheng Hu |
Organization
The First Affiliated Hospital of Sun Yat-sen University
Division name
Department of Burn Surgery
Zip code
Address
58 Zhongshan Road II, Guangzhou 510080, China
TEL
+86-20-87755766-8235
Homepage URL
willway128@163.com
Sponsor or person
Institute
Department of Burn Surgery
The First Affiliated Hospital of Sun Yat-sen University
Institute
Department
Personal name
Funding Source
Organization
National Natural Science Foundation of China (30973128, 81272096)
Sun Yat-sen University Clinical Research 5010 Program (2013001)
Organization
Division
Category of Funding Organization
Other
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 | 02 | Month | 22 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 22 | Day |
Last modified on
| 2014 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
