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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое Custom Insole + Standard Care
  The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.
• Другое 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).

Первичные конечные точки

• Pain Intensity [Срок оценки: 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: [Срок оценки: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.]
• Wound Healing [Срок оценки: 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.]

Вторичные конечные точки (2)

• Risk of fall [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

11\. Dementia or impaired cognitive function

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• University of Lahore — Lahore

Идентификаторы

NCT: NCT07109895 · Custom Insole with TENS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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