RecruitingNot ApplicableNCT07109895

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

Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers

Sponsor

University of Lahore

Enrollment

40 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

18-60 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

Exclusion Criteria10

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

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Interventions

OTHERStandard Care Only

Standard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.

OTHERTENS plus Standard Care

This experimental group will receive the same intervention plus Transcutaneous Electrical Nerve Stimulation (TENS) in burst mode (1-4 Hz at 100 Hz) applied around the wound site for 30 minutes, along with standard care.

OTHERCustom Insole + Standard Care

The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.

OTHERTENS + Custom Insole + Standard Care

Participants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs).