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

Sponsor: University of Lahore • ClinicalTrials.gov ID: NCT07109895

Registry updated: 2026-10-09

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Description

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.

Interventions

Standard Care Only (Other)
Standard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.
Custom Insole + Standard Care (Other)
The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.
TENS + Custom Insole + Standard Care (Other)
Participants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs).

Eligibility criteria

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

Conditions

Diabetic Foot Ulcer

Locations

University of Lahore — Lahore, Punjab Province, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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