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Investigation of the safety of allogeneic mesenchymal stem cell transplantation derived from adipose tissue in patients with diabetes

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130811014330N11
Enrollment
9
Registered
2026-04-17
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot ulcer.

Interventions

Intervention 1: 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

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Reza Rahimi

Mashhad University of Medical Sciences

rahimihr@mums.ac.ir+98 51 3800 2301

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026