This study aims to evaluate the effect of amniotic membrane and amniotic membrane seeded with stem cells on healing and closure time of chronic wounds. Actually, providing a tissue-engineered product using amniotic membrane as a scaffold and adipose tissue-derived mesenchymal stem cells for healing of diabetic ulcers will be investigated by the present study.
Design
This is a phase I and II clinical trial interventional study. Regardless of gender, people with the age of 15-45 were selected. The total of 32 patients have been considered as the study sample size and randomly interred to the determined groups.
Settings and conduct
The present study is conducted in the diabetes clinic 1-endocrinology and metabolism research institute. The evaluation of wound closure levels is performed on days 7-14-21 using photographic analyzes and Image J software has been used for data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Signature of informed consent,
Grade 1 or 2 wound on the Wagner scale,
With a diagnosis of diabetic or other chronic wounds, Female or male patient aged 15-45
Not pregnant
Primary Outcome Measures: Ulcer Healing Rate
Secondary Outcome Measures: Time to ulcer healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191007045008N1
Registration date:2020-01-17, 1398/10/27
Registration timing:registered_while_recruiting
Last update:2020-01-17, 1398/10/27
Update count:0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
babak arjmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 4367
Email address
barjmand@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of tissue-engineered adipose-derived mesenchymal stem cells for wound healing in diabetes
Public title
Cell Therapy in wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signature of informed consent
Grade 1 or 2 wound on the Wagner Scale
With diagnosis of diabetic or other chronic wound
Female or male patient aged 15-45
Not pregnant
Exclusion criteria:
Patients with a history of uncontrolled disease
Pregnancy
Subjects with cancerous or pre-cancerous lesions in the area to be treated
Patient with working activity who cannot be on sick-leave during the study period
Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
Age
From 15 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Endocrine & Metabolism Research Institute Ethics Committee
Street address
No.111,19th st., North Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14579-65597
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.tums.emri.rec.1396.00193
Health conditions studied
1
Description of health condition studied
diabetes mellitus type 1
ICD-10 code
E10.621
ICD-10 code description
Type 1 diabetes mellitus with ulcer
Primary outcomes
1
Description
Ulcer Healing Rate
Timepoint
7-14-21
Method of measurement
Ulcer Surface Area Measurement Using Instant Full-Scale Photography and analysis using Image J
Secondary outcomes
1
Description
Time to ulcer healing
Timepoint
7-14-21
Method of measurement
Instant full scale photography and analysis using Image J