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A Comparative Evaluation of the safety of acellular dermal matrix transplantation combined with adipose-derived mesenchymal stem cells versus standalone adipose-derived mesenchymal stem cell injection in the traetment of diabetic foot ulcers refractory to standard thrapies

Protocol summary

Study aim
To detrmine the effects of adipose-derived mesenchymal stem cells (ASC) and acellular dermal matrix (ADM) on the healing of diabetic foot ulcers in patients resistant to conventional treatments
Design
A clinical trial with the control group (before and after), with parallel groups, on 9 patients
Settings and conduct
In this study, 9 patients with treatment-resistant diabetic foot ulcers on the Wagner scale will be selected in Imam Reza hospital and divided into 3 groups. The injection will be repeated weekly for a duration of 4 weeks. The healing rate of diabetic foot ulcers is evaluated for 3 months. Blood samples will be collected before and after the intervention for gene analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Type 1 or 2 Diabetes, Diabetic ulcer grade 1 to 4, Wound duration of more than 4 weeks, No receipt of biological medications; Exclusion Criteria: History of bone infection (osteomyelitis), Presence of exposed bone in the wound, Infected diabetic foot, Concurrent participation in other clinical trials
Intervention groups
Group 1: The locally administration of 1.5 x 10^6 adipose-derived stem cells (ASC) in days of 0, 7, 14, 21. Group 2: The combination therapy of locally administration of 1.5 x 10^6 adipose-derived stem cells and acellular dermal matrix (ADM) in days of 0, 7, 14, 21. Control group: the common treatment includes a combined treatment surgery, infection control,..
Main outcome variables
Wound size, The expression level of inflammatory genes IL-6 and IL-1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130811014330N11
Registration date: 2026-04-17, 1405/01/28
Registration timing: prospective

Last update: 2026-04-17, 1405/01/28
Update count: 0
Registration date
2026-04-17, 1405/01/28
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-07-21, 1405/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Evaluation of the safety of acellular dermal matrix transplantation combined with adipose-derived mesenchymal stem cells versus standalone adipose-derived mesenchymal stem cell injection in the traetment of diabetic foot ulcers refractory to standard thrapies
Public title
Investigation of the safety of allogeneic mesenchymal stem cell transplantation derived from adipose tissue in patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diabetic ulcer grade 1 to 4 according to Wagner's classification Having a single wound in the legs and extremities (fingers, soles, heels, on the toes) that has been at least 4 weeks old No smoking, alcohol and drug addiction Not receiving biological drugs Not having concurrent diseases such as cancers, vasculitis, kidney and liver failure, and heart failure that may cause problems in wound healing Vascular problems should not be observed in the wound (ankle-Brachial Index (ABI) should not be less than 0.7)
Exclusion criteria:
patients with history of osteomyelitis Presence of exposed bone within the wound area patient with infected diabetic foot ulcer Concurrent participation in other clinical trials Hemoglobin less than 10mg/dL
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 9
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qureshi Building of MUMS, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2025-12-06, 1404/09/15
Ethics committee reference number
IR.MUMS.REC.1404.295

Health conditions studied

1

Description of health condition studied
diabetic foot ulcer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The size of the wound
Timepoint
before traetment and days of 7, 14, 21, 28 and 3 months after traetment
Method of measurement
Digital camera

Secondary outcomes

1

Description
Expression of inflammatory gene IL-6
Timepoint
before the intervention and 3 months after the completion of intervention
Method of measurement
Gene expression level by Real time PCR by TaqMan probe

2

Description
Expression of inflammatory gene IL-1
Timepoint
before the intervention and 3 months after the completion of intervention
Method of measurement
Gene expression level by Real time PCR by TaqMan probe

Intervention groups

1

Description
Control group: The patients in the control group are treated with routine dressing. The common treatment for these patients is a combined treatment including surgery, infection control, etc., which is prescribed to the patient at the discretion of the treatment staff and depending on the type and severity of the wound.
Category
Other

2

Description
Intervention group 1: The locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) in days of 0, 7, 14, 21 (In this group, the injection will be once a week for a month). Depending on the area of the wound, up to 5 ml (per session) of the cell by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged with a wet silicone bandage. Wet silicone dressing is changed every three days.
Category
Treatment - Drugs

3

Description
Intervention group 2: The combination therapy of locally administration of 1.5 x 10^6 adipose-derived stem cells (ADSCs) (allogen, viracell) and acellular dermal matrix in days of 0, 7, 14, 21 (In this group, the injection will be once a week for a month). Depending on the area of the wound, up to 5 ml (per session) of the cell by the surgeon is injected. It should be noted that the injection is done at several points of the edges of the wound so that the environment of the edge of the wound is properly covered. After that, the wound is bandaged first with acellular dermal matrix and then with a wet silicone bandage. Wet silicone dressing is changed every three days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hamid Reza Rahimi
Street address
Imam Reza Hospital, Imam Reza Sq, Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
rahimihr891@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3854 3031
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
MD, Ph.D, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Faculty of Medicine, Azadi Square, Pardis Campus,Vakil Abad Boulevard, Mashhad-Iran,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1800 2288
Fax
+98 51 1800 2287
Email
rahimihr891@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rahimi
Position
MD, Ph.D, associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical documentation will be published while maintaining confidentiality principles.
When the data will become available and for how long
One year after the end of sampling
To whom data/document is available
researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further and supplementary research
From where data/document is obtainable
Dr Hamid Reza Rahimi
What processes are involved for a request to access data/document
Approved by the Research Committee of Mashhad University of Medical Sciences
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