Evaluation of safety and efficacy of using exosome harvested from human umbilical cord mesenchymal stem cells (hucMSCs) in diabetic foot ulcer patients (Clinical trial Phases I,II)
The aim of this study is to investigate the safety and efficacy of exosomes derived from mesenchymal stem cells in the treatment of diabetic wounds.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 1 and 2 on 80 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In sterile conditions, the umbilical cord is separated and its mesenchymal cells are separated, and finally, to stimulate the production of extracellular vesicles in closed conditions and a sterile environment, the bioreactor manufactured by Corning will be used. Using ultracentrifuge, extracellular vesicles will be separated. Then they will be used for the studied groups within 20 days. A double-blind study by Qazvin University of Medical Sciences Province Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 30 to 60 years; type one or two diabetes; lack of active infection; free of necrotic remains; blood glycosylated hemoglobin level less than or equal to 10%;
Exclusion criteria:
non-diabetic ulcer; Antibiotics; infection; renal failure; liver failure; AIDS; Allergy to natural protein and polysaccharide; pregnancy or breastfeeding; alcohol or drug abuse; history of malignant tumor surgery; use of corticosteroids and immunosuppressive drugs;
Intervention groups
Patients are divided into four groups receiving scrotum spray, receiving hydrogel-scrotum composite dressing, receiving scrotum spray combined with hydrogel-scrotum composite dressing, and receiving routine dressing (20 people in each group).
Main outcome variables
The gender of the patients; age of patients; death rate; severe side effects; wound closure rate; infection; local adverse effects; skin edema; Neuropathy, group; the healing status of the patient's wound; Follow-up time of patients after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240317061316N1
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Hossein Piri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6005
Email address
hosseinpiry@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of using exosome harvested from human umbilical cord mesenchymal stem cells (hucMSCs) in diabetic foot ulcer patients (Clinical trial Phases I,II)
Public title
Investigating the safety and efficacy of stem cell exosomes on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Voluntary participation in the research by complying with the requirements of the protocol and accepting the steps related to its implementation and signing the informed consent form
Age over 30 years and less than 60 years
Suffering from type I or type II diabetes
Diabetic foot ulcer size between 1 cm2 to 12 cm2
Type II or type III wound with Wagner grading and spread to skin, tendon and subcutaneous tissue without evidence of active wound infection at the time of eligibility to participate in the study
Free of necrotic remnants in the target wound
Blood glycosylated hemoglobin level (HbA1c) <=10%
Satisfactory perfusion to the wound as confirmed by measurement of systolic blood pressure in the posterior or anterior tibial artery (>50 mmHg) of the affected limb
General health status, which according to the researcher, allows the patient to participate in all stages of the study
Exclusion criteria:
1. Non-diabetic pathophysiological wound.
2. People who need intravenous (IV) antibiotics to treat infection.
3. Current evidence of infection, including drainage of pus from the wound site.
4. People with severe kidney failure who cannot be managed with kidney dialysis.
5. People with severe liver failure.
6. Human immunodeficiency virus (HIV) positive
7. People who have an allergic reaction or hypersensitivity to natural proteins and polysaccharides.
8. Pregnancy or breastfeeding
9. People with a clinical history related to alcohol or drug abuse.
10. Suffering from a disease that can affect the study.
11. People who have had a history of malignant tumor surgery in the last five years (with the exception of carcinoma in situ).
12. People who are currently enrolled or in another clinical study.
13. People who have undergone wound treatment with growth factors, skin substitutes or other biological treatments in the last 30 days.
14. People who receive oral or injectable corticosteroids, immunosuppressant or cytotoxic drugs with unstable dosage before 4 weeks.
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants (men and women) with DFU using random block method using blocks of 4 and 8 and RAS (Random Allocation Software) and allocation ratio 1:1:1:1
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the outcome assessor do not know the type of treatment received.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran national committee for ethics in biomedical Research
Street address
ًQazvin University of medical science, Bohunar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.QUMS.REC.1402.330
Health conditions studied
1
Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Wound closure rate
Timepoint
Wound healing rate after 1, 7, 14, 28, 60
Method of measurement
Wound size is evaluated using a 3D digital wound imaging device with image processing software.
Secondary outcomes
1
Description
Amputation rate
Timepoint
The amount of amputation after 1, 7, 14, 28 days
Method of measurement
Tissue size
2
Description
Skin edema
Timepoint
The amount of skin edema after 1, 7, 14, 28 days
Method of measurement
Reduction of swelling and accumulation of fluids with the weight grading system for skin size results in +1 to +4. It is evaluated by applying pressure on the damaged area and then measuring the depth of the pit (with a ruler) and its duration (return time). Degree of +1 to 2 mm indentation, setting the return time using a timer
3
Description
Infection
Timepoint
The rate of infection after 1, 7, 14, 28 days
Method of measurement
Bacterial culture
Intervention groups
1
Description
Intervention group 1: people with diabetic foot ulcers who receive secretum for the treatment of diabetic foot ulcers
Category
Treatment - Drugs
2
Description
Intervention group 2: People with diabetic foot ulcers who receive normal treatment for their diabetic foot ulcers
Category
Treatment - Drugs
3
Description
Intervention group 3: People with diabetic foot ulcers who receive normal and secretum treatment to treat their diabetic foot ulcers
Category
Treatment - Drugs
4
Description
Control group: people with diabetic foot ulcers who receive normal treatment for the treatment of diabetic foot ulcers
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Teaching Center
Full name of responsible person
Hossein Piri
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6005
Email
hosseinpiry@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirhashemi
Street address
Shahid Beheshti Boulevard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Piri
Position
Associate Professor of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6005
Email
hosseinpiry@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Piri
Position
Associate Professor of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6005
Email
hosseinpiry@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Piri
Position
Associate Professor of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6005
Email
hosseinpiry@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available