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

University of Lahore

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Other: Standard Care Only; Other: TENS plus Standard Care; Other: Custom Insole + Standard Care; Other: TENS + Custom Insole + Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07109895

Custom Insole with TENS

Details and patient eligibility

About

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.

Full description

Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.

Offloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

10. Dementia or impaired cognitive function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Standard Care Only

Other group

Description:

Participants will receive standard care for diabetic foot ulcers.

Treatment:

Other: Standard Care Only

Custom Insole + Standard Care

Experimental group

Description:

Participants will receive a custom insole along with standard care.

Treatment:

Other: Custom Insole + Standard Care

TENS + Custom Insole + Standard Care

Experimental group

Description:

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

Treatment:

Other: TENS + Custom Insole + Standard Care

TENS + Standard Care

Experimental group

Description:

Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.

Treatment:

Other: TENS plus Standard Care