NCT07109895 Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers
| NCT ID | NCT07109895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Lahore |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-10 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy
STUDY DIRECTOR
University of Lahore
Frequently Asked Questions
Who can join the NCT07109895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109895 currently recruiting?
Yes, NCT07109895 is actively recruiting participants. Contact the research team at ayeshabutt031@gmail.com for enrollment information.
Where is the NCT07109895 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07109895 clinical trial?
NCT07109895 is sponsored by University of Lahore. The principal investigator is Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy at University of Lahore. The trial plans to enroll 40 participants.