Study on the effects of dry needling on healing outcomes of foot ulcers from diabetes: A randomized clinical trial
Not Applicable
Recruiting
- Conditions
- Diabetic foot ulcer.
- Registration Number
- IRCT20230724058903N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method lcer 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 Outcome Measures
Name Time Method 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.