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

Sponsor
University of Lahore
Study ID
NCT07109895
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 7, 2025
Start date
Aug 10, 2025
Status verified
Aug 2025
Primary completion
Jan 30, 2026
Completion
Jan 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard Care Only
    Participants will receive standard care for diabetic foot ulcers.
  • Experimental: Custom Insole + Standard Care
    Participants will receive a custom insole along with standard care.
  • Experimental: TENS + Custom Insole + Standard Care
    Participants will receive TENS therapy, a custom insole, and standard care.
  • Experimental: TENS + Standard Care
    Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.

Primary Outcome Measure

Pain Intensity [ 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. ]

Central Contacts

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