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

University of Lahore40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Standard Care OnlyOTHER

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.

TENS plus Standard CareOTHER

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.

Custom Insole + Standard CareOTHER

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

TENS + Custom Insole + Standard CareOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Intensity

Pain intensity will be measured using a visual analogue scale. It is an 11-point scale where "0" indicates no pain and "10" indicates the worst possible pain.

Time frame: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.

Dynamic Balance:

The time up and go (TUG) scale will be used for measuring dynamic balance. A time score of ≤10 seconds is considered normal, and a time of ≥14 seconds has been shown to indicate a high risk of falls.

Time frame: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.

Wound Healing

Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.

Time frame: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.

Secondary Outcomes

Risk of fall

The Tinetti Scale will be used to measure the risk of fall. The final score of the scale is 28 points, and the interpretation is as follows: 25-28 = low risk of falls; 19-24 = moderate risk of falls; and \<19 = high risk of falls.

Time frame: Risk of fall will be measured at baseline, and change in status will be measured at the 4th week, 8th week, and 12th week of the treatment session.

Toe Muscle Strength

The paper grip test (PGT) will be used to measure toe muscle strength.

Time frame: Toe Muscle Strength will be measured at baseline, and change in strength will be measured at the 4th week, 8th week, and 12th week of the treatment session.