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

Key facts

Who runs it
University of Lahore
Where
Pakistan1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
159 people, planned
Started
10 Aug 2025
Expected to end
30 Jun 2027
Type of study
Interventional, 3 groups
Treatments tested
  • Standard Care Only
  • Custom Insole + Standard Care
  • TENS + Custom Insole + Standard Care
Record updated
9 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • ≥ 18 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

Who cannot take part

  • History of amputation (proximal to the trans-metatarsal joint)
  • Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)
  • The presence of any allergic condition of the skin,
  • Use of a cardiac pacemaker,
  • 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
  • Active or inactive Charcot foot
  • Leg length discrepancy
  • Chronic consumption of opioids,
  • Major bone operation,

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Standard Care OnlyOther group

    Participants will receive standard care for diabetic foot ulcers.

  • Custom Insole + Standard CareTreatment being tested

    Participants will receive a custom insole along with standard care.

  • TENS + Custom Insole + Standard CareTreatment being tested

    Participants will receive TENS therapy, a custom insole, and standard care.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
Record updated
9 October 2026