Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Pakistan
University of Lahore
RECRUITING
Lahore
Contact Information
Primary
Ayesha Jamil, M.Phil Physiotherapy
ayeshabutt031@gmail.com
+92 324 4481031
Backup
Maryam Shabbir, PhD Rehabilitation
maryam.shabbir@uipt.uol.edu.pk
+92 300 4391550
Time Frame
Start Date: 2025-08-10
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Lahore