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

Phase 1

• Conditions: Diabetic foot ulcers.; Type 2 diabetes mellitus with foot ulcer; E11.621

• Registration Number: IRCT20210212050334N2
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.