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

Recruiting now · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT07109895

Run by

University of Lahore

People needed

40

Starts

2025-08-10

Expected to finish

2026-01-30

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-60 years old with type 1 and 2 diabetes
• Both Males and Females
• Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification

You may not qualify if…

• History of amputation (proximal to the trans-metatarsal joint)
• Active or inactive Charcot foot
• Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)
• Leg length discrepancy
• The presence of any allergic condition of the skin,
• Chronic consumption of opioids,
• Use of a cardiac pacemaker,
• Major bone operation,
• Neurological illness, such as a vestibular disorder with a history of dizziness 10. Mental disorders, which might interfere with the assessment process
• Dementia or impaired cognitive function

Where it is running

• University of Lahore — Lahore, Punjab Province, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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