Back to resultsStudy of ReCell® Treating for Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ReCell®
skin graft
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, ReCell
Eligibility Criteria
Inclusion Criteria:
- Patients aged over 18 years old
- 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:
- 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 12.0%)
Sites / Locations
- Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ReCell®
skin graft
Arm Description
ReCell® with skin graft
split-thickness skin graft as control group
Outcomes
Primary Outcome Measures
healing rate
the percentage of subjects that achieved complete wound closure by week 4, herein complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
Secondary Outcome Measures
recurrent rate
the incidence of ulcer recurrence at months 6. Recurrence will be defined as an ulcer occurring at the same location as the healed study ulcer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02070835
Brief Title
Study of ReCell® Treating for Diabetic Foot Ulcers
Official Title
ReCell® Versus Classic Skin Grafts in Treatment of Diabetic Foot Ulcers: a Comparative Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hu Zhicheng
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the ReCell® technology with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.
Detailed Description
The primary objective of this study is to assess the effectiveness and safety of ReCell® with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic Foot Ulcer, ReCell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ReCell®
Arm Type
Experimental
Arm Description
ReCell® with skin graft
Arm Title
skin graft
Arm Type
Active Comparator
Arm Description
split-thickness skin graft as control group
Intervention Type
Device
Intervention Name(s)
ReCell®
Intervention Description
ReCell® and skin graft
Intervention Type
Procedure
Intervention Name(s)
skin graft
Intervention Description
split-thickness skin graft
Primary Outcome Measure Information:
Title
healing rate
Description
the percentage of subjects that achieved complete wound closure by week 4, herein complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
Time Frame
postsurgery week 4
Secondary Outcome Measure Information:
Title
recurrent rate
Description
the incidence of ulcer recurrence at months 6. Recurrence will be defined as an ulcer occurring at the same location as the healed study ulcer
Time Frame
postsurgery months 6
Other Pre-specified Outcome Measures:
Title
complication rate
Description
the percentage of subjects that who could not achieved complete wound closure by week 4
Time Frame
postsurgery week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged over 18 years old
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:
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 12.0%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhicheng Hu, sub PI
Phone
+86 02087755766
Ext
8235
Email
willway128@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Zhu, PI
Organizational Affiliation
Department of Burns, The First Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhicheng Hu, doctor
Phone
+86 02087755766
Ext
8235
Email
willway128@163.com
12. IPD Sharing Statement
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Study of ReCell® Treating for Diabetic Foot Ulcers
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