Patients with diabetic ulcers. Type 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Intervention 1: Intervention group: Recipients of two million mesenchymal stem cells in a hydrogel carrier. Intervention 2: Control group: Recipients of standard treatment.
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals with type 1 or type 2 diabetes who have had non-healing wounds for at least four weeks Diabetic ulcer grade 1–2 on the Wagner scale; ankle-brachial index (ABI) = 0.7; HbA1c < 12 %; wound size 2–20 cm² No use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic drugs
Exclusion criteria
Exclusion criteria: Use of corticosteroids, immunosuppressive agents, and cytotoxic drugs Pregnancy and breast feeding Presence of renal failure (serum creatinine > 3 mg/dL); heart failure; uncontrolled systemic infection; neuropathic disorders other than diabetic neuropathy; peripheral vascular disease; and psychiatric illness or disability Age over 80 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound surface size. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: Measuring tool.;Wound healing rate. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: macroscopic evaluation.;Severity of wound pain. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: Pain score on a numeric rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival Risk Percentage. Timepoint: day 365. Method of measurement: Plotting the survival curve.;Risk of Amputation. Timepoint: 12 months after intervention. Method of measurement: Clinical Documentation.;Wound-Related Quality of Life Index. Timepoint: 3 months after intervention. Method of measurement: Wound-QoL. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHalimeh Hassanzadeh
Iranian academic center for education culture and research
Outcome results
None listed