Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients

Inclusion Criteria:

1. Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2diabetes undergoing therapy for glycemic control using available diabetes drugsincluding insulin.
2. Subject has a glycosylated hemoglobin, HbA1c ≤ 12%.
3. Subjects maintain regular/stable blood purification treatment of hemodialysis (HD) orperitoneal dialysis (PD) for ≥6 months prior to Visit 0.
4. Presence of at least one diabetic foot ulcer that meets all of the following criteria:
5. A full-thickness ulcer of UTWCS Grade I-A or II-A
6. Ulcer size (area) is > 1 cm² and ≤ 10 cm² (post-debridement at time ofenrollment)
7. Ulcer is located on or below the malleoli.
8. Ulcer presents for > 4 weeks (at time of enrollment).
9. There is a minimum 3 cm margin between the qualifying Target Ulcer and any otherulcers on the specified foot, (post-debridement).
10. No active infection by clinical inspection as defined by IDSA/IWGDF criteria.Note: If the subject has more than one qualifying diabetic foot ulcer, the mostsevere ulcer will be designated as the target ulcer; meanwhile, the depth of thewound will the consideration prior to the area of the wound.
11. Subject has adequate vascular perfusion of the affected limb, confirmed byAnkle-Brachial Index (ABI) ≥0.7 and < 1.3, transcutaneous pressure of oxygen (TcPO2) ≥30 mmHg on at least one lead, or Doppler ultrasound related test to ensure no seriousembolisms/no serious clogging of blood vessels. .
12. Subject, if female of child-bearing potential, has a negative serum pregnancy test atscreening, must not be breastfeeding, and willing to use 2 medically accepted methodsof contraception (e.g., barrier contraceptives [female condom, or diaphragm with aspermicidal gel], hormonal contraceptives [implants, injectable, combination oralcontraceptives, transdermal patches, or contraceptive rings], and intrauterinedevices) during the course of the study (excluding women who are not of childbearingpotential and/or who have been sterilized).
13. Subject is willing to use an off-loading device for the target ulcer on the plantarwhile ambulation for the duration of the study.
14. Subject / identified caregiver trained on the study procedures is able and willing tocomply with study procedures.
15. A signed and dated informed consent form has been obtained from the subject prior toany study-related procedures being performed.

Exclusion Criteria:

1. In response to standard of care, ulcer size reduction is > 30% during the two-weekrun-in Screening Period (between the first Screening Visit/V0 and Baseline/V1).
2. Body mass index (BMI) > 35 kg/m2
3. Laboratory values at Screening of:
4. Hemoglobin < 6.0 g/dL
5. White Blood Cells (WBC) < 3.0 X 103 cells/uL； > 12.0 X 103 cells/uL
6. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) andalanine transaminase (ALT)] > 3x the upper limit of normal
7. Albumin < 2.5 g/dL
8. Presence of any clinically significant medical condition(s) in medical history duringscreening period that, in the opinion of the investigator, could interfere with woundhealing, including but not limited to the following:
9. Acute or unstable Charcot foot
10. Active malignant disease. A subject, who has had a malignant disease in the past,was treated and is currently disease-free, may be considered for study entry.
11. Acquired immune deficiency syndrome (AIDS) or HIV positive.
12. Subject is currently receiving (i.e., within 30 days of enrollment visit) or scheduledto receive any of following medication or therapies, could interfere with woundhealing during the course of the study.
13. immunosuppressant (including chronic systemic corticosteroids)
14. cytotoxic chemotherapy
15. cytostatic therapy
16. autoimmune disease therapy
17. growth factors
18. hyperbaric oxygen therapy
19. bioengineered tissue or skin substitutes（ADM）
20. application of topical steroids to the ulcer
21. use of any investigational drug(s)
22. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drugabuse, determined from the subject's medical history, which, in the opinion of theinvestigator, may pose a threat to subject compliance.
23. Has any other factor which may, in the opinion of the investigator, compromiseparticipation and/or follow-up in the study. Note ( Based on TEXAS 1A, 2A, the below information is to further calcification, andpotential subjects meeting any of the following items will be excluded from thestudy.) :
24. Ulcers with exposed bone or associated with osteomyelitis. (The osteomyelitisshould be ruled out by clinical examination (probing of the wound) or X-rayfindings as deemed necessary by the Investigator.)
25. Presence of necrosis, purulence or sinus tracts that cannot be removed bydebridement.
26. Current sepsis
27. Subjects who need to stand continuously for more than 4 hours / day and havedifficulty complying with off-loading instructions.
28. The following products and ulcer care materials should NOT be used on or around theTarget Ulcer after the first Screening Visit or at any time during the Treatment Phaseof the study.
29. Topical antibiotics, antiseptic soaps, steroids, or any other topical agents onthe Target Ulcer. Note: Topical medication applied to the skin surrounding the Target Ulcer isallowed. (i.e. Skin barrier prep to protect peri-wound skin.)
30. Hydrocolloid dressings are allowed only during the screening period but are notpermitted after randomization.
31. Hydrogelsare allowed only during the screening period but are not permitted afterrandomization.
32. Silver nitrate hemostatic sticks or styptic pencils
33. Negative pressure assisted closure device
34. Heat lamps
35. UV lights
36. Whirlpool baths
37. Water Piks
38. Hyperbaric Oxygen
39. Jet water streams (other than gentle saline irrigation) on the leg with TargetUlcer
40. Ulcer dressings that include growth factors, engineered tissues or skinsubstitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®,Primatrix®, Matristem®, etc.) on all ulcers including non-target ulcers duringthe Treatment Phase.
41. Revascularization surgery on the leg with Target Ulcer
42. Systemic steroids/oral corticosteroids (NOTE: inhaled steroids are acceptable)
43. Other Immunosuppressive agents
44. Autoimmune disease therapies
45. Cytostatic drugs
46. Any other investigational treatment/medications