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Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers

RecruitingNAAges 18 Years - anyAllUniversity of Lahore
NCT07109895 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥ 18 years old with type 1 and 2 diabetes 2. Both Males and Females 3. Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification Exclusion Criteria: 1. History of amputation (proximal to the trans-metatarsal joint) 2. Active or inactive Charcot foot 3. Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS) 4. Leg length discrepancy 5. The presence of any allergic condition of the skin, 6. Chronic consumption of opioids, 7. Use of a cardiac pacemaker, 8. Major bone operation, 9. Neurological illness, such as a vestibular disorder with a history of dizziness 10. Mental disorders, which might interfere with the assessment process 11\. Dementia or impaired cognitive function
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What it tests

  • Standard Care Only
  • Custom Insole + Standard Care
  • TENS + Custom Insole + Standard Care
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Where

1 site
University of Lahore
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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