The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented.

Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation.

Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The "worsened" means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE).

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

Total of all reporting groups

Race and Ethnicity were not collected from any participant.

The target ulcer is classified as Grade 0 ~ 5 according to modified Wagner system. The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades: grade 0 (pre-or postulcerative lesion), grade 1 (partial/full thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene), and grade 5 (whole foot gangrene). Higher grades were considered worse.

Defined as the time to complete ulcer closure.

All randomized subjects who have received at least one dose of study medication.

Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements observed for at the last two consecutive study visits 2 weeks apart. The count of participants with complete ulcer closure at each post-treatment visit is provided.

All randomized patients who have received at least one dose of study medication.

The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented.

All randomized patients who have received at least one dose of study medication.

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication, whether or not related to the study medication. AE data was collected from Screening visit to Final visit (up to 24 weeks).

All randomized patients who have received at least one dose of study medication.

Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation.

All randomized patients who have received at least one dose study medication.

Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The "worsened" means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE).

All randomized patients who have received at least one dose study medication.

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

All randomized patients who have received at least one dose of study medication.

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

All randomized patients who have received at least one dose of study medication.

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

All randomized patients who have received at least one dose of study medication.

Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).

All randomized patients who have received at least one dose of study medication.

The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 50% reduction in target ulcer size was measured from Screening visit to Final visit (up to 24 weeks).

All randomized patients who have received at least one dose of study medication.

The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). A subject who had target ulcer closure ≥ 50% was counted as a responder. The non-responders included subjects whose target ulcer closure size less than 50% before 12 weeks.

All randomized patients who have received at least one dose of study medication.

The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 90% reduction in target ulcer size was analyzed in the subjects.

All randomized patients who have received at least one dose of study medication.

Subjects with ulcer closure size ≥ 90% compared to the baseline at a Week 12 were considered as a responder. A subject whose target ulcer size reduction was less than 90% was counted as a non-responder. The percentage of repsonders and non-responders were presented.

All randomized patients who have received at least one dose of study medication.

Matched vehicle, topical, two times daily