Custom insoles and TENS for healing and pain relief in diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares four care approaches for adults aged 18–60 with Wagner Grade 1–2 diabetic foot ulcers: standard care alone, standard care plus TENS, standard care plus a custom insole, and standard care with both TENS and a custom insole. Participants receive offloading and wound management per standard protocols, with TENS and custom insoles provided to the appropriate groups. Clinical outcomes such as ulcer healing, pain levels, functional status, and adverse events will be monitored over the treatment period. The trial is conducted at the University of Lahore, with participants recruited and treated at that clinical site.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Lahore
  Lahore, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Ayesha Jamil, M.Phil Physiotherapy
• Email: ayeshabutt031@gmail.com
• Phone: +92 324 4481031

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.