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

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

Recruiting
18-60 years
All
Phase N/A

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Overview

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.

Description

Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.

Offloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.

Eligibility

Inclusion Criteria:

  1. 18-60 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
  10. Dementia or impaired cognitive function

Study details
    Diabetic Foot Ulcer

NCT07109895

University of Lahore

12 September 2025

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