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The use of stem cells loaded on nanofiber tissue scaffolds to repair the diabetic foot ulcer

Investigation of the therapeutic potential of fibroblast and adipose-derived mesenchymal stem cells loaded on nanofiber scaffolds for healing the diabetic foot ulcer in diabetic patients and comparison with common procedures.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190214042712N1
Enrollment
20
Registered
2019-09-17
Start date
2015-09-23
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Diabetic foot ulcer. Diabetes mellitus with peripheral circulatory complications

Interventions

Intervention 1: Intervention group: Diabetic patients with foot ulcer will receive stem cell therapy in addition to routine treatment. The stem cells will be loaded on nanofiber scaffolds in the centr

Sponsors

Iran National Science Foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 21 to 65 years old Having diabetic foot wounds that have not recovered despite a cure during the past month (2-7 cm) Feeling pain at rest and walking Signature written consent

Exclusion criteria

Exclusion criteria: Patients over 65 years old Pregnancy or breastfeeding The presence of septicemia Other systemic diseases in which the kidney is involved, such as cancer, autoimmune diseases, blood diseases, liver disease and ... Hospitalization due to serious illness in the past two months Severe malnutrition The presence of foot ulcer due to all reasons except for diabetes, for example, syphilis, tuberculosis, or fungal foot Any allergy to the compounds used in the cell culture process

Design outcomes

Primary

MeasureTime frame
Wound size based on cm2. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: By multiplying the length of the wound by depth of the wounds.;The distance that the patient can walk without pain. Timepoint: Before treatment and at every 1 and 2 weeks after treatment. Method of measurement: Meter.;Biochemical markers including ALT, AST, Bilirubin, FBS, TG, Cholesterol, BUN, Cr. Timepoint: Before and after treatment. Method of measurement: Biochemical tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRokhsareh Meamar

Esfahan University of Medical Sciences

meamar@pharm.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026