Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers
NCT ID: NCT02070835
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-04-30
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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autologous skin cell
autologous skin cell with skin graft
autologous skin cell
autologous skin cell and skin graft
skin graft
split-thickness skin graft as control group
skin graft
split-thickness skin graft
Interventions
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autologous skin cell
autologous skin cell and skin graft
skin graft
split-thickness skin graft
Eligibility Criteria
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Inclusion Criteria
* with a diagnosis of type 1 or type 2 diabetes
* who had a diabetic low extremity ulcer last for over 4 weeks
* with a stage 2 by Wagner's scale
* size more than 3 cm2
* absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2)
* had indications of skin grafting were eligible for inclusion
Exclusion Criteria
* using corticosteroids or immunosuppressor
* a high anesthesiology or surgical risk
* uncontrolled hyperglycemia (preoperative HbA1c greater than 12.0%)
18 Years
85 Years
ALL
No
Sponsors
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Hu Zhicheng
OTHER
Responsible Party
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Hu Zhicheng
FirstSunYetSen
Principal Investigators
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Jiayuan Zhu, PI
Role: PRINCIPAL_INVESTIGATOR
Department of Burns, The First Affiliated Hospital, Sun Yat-sen University
Locations
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Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SYSU-2013-048
Identifier Type: -
Identifier Source: org_study_id
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