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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a four-arm parallel-group interventional study designed to evaluate the effects of transcutaneous electrical nerve stimulation (TENS), custom insoles, and their combination in addition to standard care in patients with diabetic foot ulcers (DFUs). Participants will be randomly assigned to one of the following groups:

Group 1: Standard care alone Group 2: TENS + standard care Group 3: Custom insole + standard care Group 4: TENS + custom insole + standard care

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will be kept blinded of treatment group.

Study Groups

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Standard Care Only

Participants will receive standard care for diabetic foot ulcers.

Group Type OTHER

Standard Care Only

Intervention Type OTHER

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.

Custom Insole + Standard Care

Participants will receive a custom insole along with standard care.

Group Type EXPERIMENTAL

Custom Insole + Standard Care

Intervention Type OTHER

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

TENS + Custom Insole + Standard Care

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

Group Type EXPERIMENTAL

TENS + Custom Insole + Standard Care

Intervention Type OTHER

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).

TENS + Standard Care

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

Group Type EXPERIMENTAL

TENS plus Standard Care

Intervention Type OTHER

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.

Interventions

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Standard 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.

Intervention Type OTHER

TENS 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.

Intervention Type OTHER

Custom Insole + Standard Care

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

Intervention Type OTHER

TENS + 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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No