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