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.
≥ 18 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
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
Parallel
Standard Care Only
Other interventionStandard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.
Custom Insole + Standard Care
Other interventionThe experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.
TENS + Custom Insole + Standard Care
Other interventionParticipants 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).
Wound Healing
Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.
Risk of fall
The Tinetti Scale will be used to measure the risk of fall. The final score of the scale is 28 points, and the interpretation is as follows: 25-28 = low risk of falls; 19-24 = moderate risk of falls; and \<19 = high risk of falls.
Dynamic Balance:
The time up and go (TUG) scale will be used for measuring dynamic balance. A time score of ≤10 seconds is considered normal, and a time of ≥14 seconds has been shown to indicate a high risk of falls.
Pain Intensity
Pain intensity will be measured using a visual analogue scale. It is an 11-point scale where "0" indicates no pain and "10" indicates the worst possible pain.
Toe Muscle Strength
The paper grip test (PGT) will be used to measure toe muscle strength.
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