NCT07109895

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Lahore · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer

Interventions

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

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-08-07
• Last updated: 2025-08-14

Locations

1 site across 1 country: Pakistan