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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 10, 2025

Primary Completion Date

January 30, 2026

Study Completion Date

January 30, 2026

Conditions
Diabetic Foot Ulcer
Interventions
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).

Trial Locations (1)

54000

RECRUITING

University of Lahore, Lahore

All Listed Sponsors
lead

University of Lahore

OTHER

NCT07109895 - Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter