Evaluation of safety and efficacy of stromal vascular fraction on foot diabetic wound-clinical trial phase I and II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210212050334N2

Enrollment

Registered

2021-10-20

Start date

2021-12-22

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Diabetic foot ulcers. Type 2 diabetes mellitus with foot ulcer

Interventions

Intervention 1: Intervention group: The prepared SVF will be injected in the desired areas with a depth of 1 to 2 mm in a width of 1%, equal to 10 by 17 cm at intervals of 1 in 1 cm with a volume of 0

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Having chronic outpatient diabetic foot ulcer Age range from 30 to 60 years Having a single wound on the foot and limb terminals (fingers, sole, heel, toes) within four works without repair Body Mass index 18-25 ABI / TBI ratio greater than 0.9.

Exclusion criteria

Exclusion criteria: Smoking, Alcohol consumption Drug addiction Taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. A concomitant disease that may interfere with wound healing, such as cancer, vasculitis, kidney, liver, or heart failure. Osteomyelitis

Design outcomes

Primary

Measure	Time frame
Mortality rate. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Patient record.;Adverse systemic complications. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Barometer and diagnostic tests.;Fever. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Thermometer.;Infection. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Examination of the wound by the treating physician.	—

Measure

Time frame

Mortality rate. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Patient record.;Adverse systemic complications. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Barometer and diagnostic tests.;Fever. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Thermometer.;Infection. Timepoint: 24 hours and one week after SVF injection. Method of measurement: Examination of the wound by the treating physician.

—

Secondary

Measure	Time frame
Wound healing. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Examination, wound diameter decreases.;Wound edema. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Medical examinations and checklist.;Neuropathy. Timepoint: 1,7, 28 and 60 days after SVF injection. Method of measurement: Physician diagnosis and check list.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmaneh mohammadi roushandeh

Rasht University of Medical Sciences

mohammadi_roushandeh@gums.ac.ir+98 13 3336 8540

Outcome results

None listed

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