Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07109895

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

Led by University of Lahore · Updated on 2025-08-14

40

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years with type 1 or type 2 diabetes
  • Male or female gender
  • Presence of foot ulcers classified as Grade 1 or Grade 2 by Wagner Classification
Not Eligible

You will not qualify if you...

  • History of amputation above the trans-metatarsal joint
  • Active or inactive Charcot foot
  • Non-constructible peripheral vascular disease due to arteriosclerosis
  • Leg length difference
  • Any allergic skin condition
  • Chronic use of opioids
  • Use of a cardiac pacemaker
  • Major bone surgery
  • Neurological disorders like vestibular disease with dizziness
  • Mental disorders affecting assessment
  • Dementia or cognitive impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Lahore

Lahore, Punjab Province, Pakistan, 54000

Actively Recruiting

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Research Team

A

Ayesha Jamil, M.Phil Physiotherapy

CONTACT

M

Maryam Shabbir, PhD Rehabilitation

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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