Diabetic Foot Ulcer. Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention 1: In this study, a cold jet plasma rifle machine will be used as a source of helium gas jet plasma. The plasma is created in 1 day intervals and each time for 5 minutes on the wound will
Sponsors
Endocrinology and Metabolism Research Institute
Plasma physics research Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diabetic patient with infected ulcer DFU grade 2 Neuropathic and Neuroischemin Ulcer ABI>0.8 , ABI<1.3
Exclusion criteria
Exclusion criteria: Not patient compliance Ischemic ulcers Pregnancy cancer Dementia age< 18 Immunosuppressive therapy Gangrene Ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area of ulcer. Timepoint: After selecting a patient for up to 3 weeks in each visit (one day in between), the size of the patient's wound is measured. Method of measurement: take a photo with ruler and analysis it.;Microbial colony count. Timepoint: Up to 3 weeks after the patient's choice, once a week, a microbial culture of the wound secretions is performed. Method of measurement: with standard method swap.;Cytokines and growth factors. Timepoint: at the first and end of third week. Method of measurement: 128/5000Samples from ulcerous secretions are taken with pasteurized sterile pipettes and then by ELISA, cytokines and growth factors are measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of cold plasma radiation on the patient. Timepoint: During and after radiation of the plasma. Method of measurement: Ask the patient about possible symptoms and see the wound's position. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Amini
Endocrinology and Metabolism Research Institute
Outcome results
None listed