Custom insoles and TENS for healing and pain relief in diabetic foot ulcers
Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
This project will test whether adding transcutaneous electrical nerve stimulation (TENS) and/or a custom insole to usual care helps heal and reduce pain from Grade 1–2 diabetic foot ulcers in adults with diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Lahore Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07109895 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–60 with type 1 or type 2 diabetes who have Wagner Grade 1 or 2 foot ulcers are ideal candidates for this study.
Not a fit: Patients with major complicating conditions such as prior proximal amputation, Charcot foot, non-reconstructable peripheral vascular disease, implanted pacemakers, active neurological disorders, or severe cognitive impairment are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the combined use of TENS and custom insoles could speed ulcer healing, reduce pain, and lower the risk of complications or future amputations.
How similar studies have performed: Offloading with insoles has established benefits for ulcer prevention and healing and TENS has evidence for pain relief and potential tissue-healing effects, but combining TENS with custom insoles for DFU outcomes has not been well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-60 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 this trial is running
Lahore, Punjab Province
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.