Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

Demographic Characteristics: Weight (Mean)

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Demographic Characteristics: BP (Mean)

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Demographic Characteristics: ABI (Mean)

Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease. An index higher than 1.3 indicates stiff, non-compressible blood vessels which are common in diabetes. Left and right Ankle-Brachial Index (ABI) values are calculated by dividing the highest systolic pressure from each ankle (posterior tibial or dorsalis pedis artery) by the highest overall brachial (arm) systolic pressure.

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Medical Costs Due to DFUs

The total medical cost due to diabetic foot ulcers across 140 participants is reported.

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.

Percentage of Amputation

Major amputations involve removing a limb above or through the ankle (e.g., below-knee/transtibial, above-knee/transfemoral), significantly impacting mobility. Minor amputations, such as toes or metatarsal, are distal to the ankle and aim to preserve function. Total amputations include the sum of major and minor amputations.

Time frame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial.