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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Lahore

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Care Only
  • TENS plus Standard Care
  • Custom Insole + Standard Care
  • TENS + Custom Insole + Standard Care

Treatment groups

40 Participants
are divided into 4 treatment groups

Sponsors and collaborators