Diabetic foot ulcer.
Conditions
Interventions
Intervention 1: Intervention group 1: Standard treatment and Dry needling. Intervention 2: Intervention group 2: Standard treatment and Sham needling. Intervention 3: Control group: Standatd treatment
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 40 years old and above Having at least one diabetic ulcer of the neuroischemic type that is resistant to treatment (after 1 month of standard treatment, it has not yet disappeared) in the area of ??the feet and fingers. Grade 2 wound on the Wagner scale • 16 cm2 = ulcer size =1 cm2 Hba1c< %12
Exclusion criteria
Exclusion criteria: Foot ulcer with osteomyelitis or bone infection Ulcers that have healed up to 50% within 4 weeks Subjects with immune system deficiency, severe infection in the wound area Having a history of radiotherapy in the last 120 days A history of leg venous thrombosis in the last 6 months History of lymphedema, thrombocytopenia and cellulitis A history of needle phobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer area in Image j software. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: Image j software.;Measuring the depth of the ulcer using a calibrated probe. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: calibrated probe.;Measuring blood flow using ABI and TBI tests. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: ABI and TBI tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity score. Timepoint: Before the study, after first session, one month and three months after the beginning of the study. Method of measurement: Numerical rating scale.;Neuropathy severity score. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: Michigan and diabetic neuropathy questionnaires.;Vibration sensation score. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: The Neurothesiometer.;Quality of life score. Timepoint: Before the study, one month and three months after the beginning of the study. Method of measurement: Wound- QOL questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoofia Naghdi Dorabati
Tehran University of Medical Sciences
Outcome results
None listed