Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers

Inclusion Criteria:

1. Subjects, male or female, aged 18 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. Diagnosis with Diabetic Peripheral Neuropathy (DPN) or vascular disease defined byChinese guidelines for diagnosis and treatment of diabetic foot (2020 version).Subject has adequate vascular perfusion of the affected limb, no obvious clinicalmanifestations of lower limb ischemia, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8and ≤ 1.3, or transcutaneous pressure of oxygen (TcPO2) > 30 mmHg on at least onelead.

4. An ulcer of Wagner Grade II.

5. Presence of at least one diabetic foot ulcer that meets all of the followingcriteria:

6. Ulcer size (area) is > 1 cm2 and ≤ 25 cm2 (post-debridement at time ofscreening and randomization)

7. Ulcer is located on or below the malleoli and presents duration of between 4weeks and 12 months (at time of screening).

8. If there are more than two ulcers, there should be a minimum 3 cm marginbetween the qualifying Target Ulcer and any other ulcers on the specified foot (post- debridement).

9. 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. Severity will bedetermined by the investigator's assessment.

10. Subject, if a female of child-bearing potential, has a negative serum pregnancy testat screening, and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [female condom, or diaphragm with a spermicidal gel],hormonal contraceptives [implants, injectables, combination oral contraceptives,transdermal patches, or contraceptive rings], and intrauterine devices) during thestudy (excluding women who are not of childbearing potential and/or who have beensterilized).

11. Subject should be able to walk and stand on the non-target ulcer limb.

12. Subject is willing to use an off-loading device for the target ulcer on the plantarwhile ambulation for the duration of the study

13. Subject and/or trained identified caregiver is able and willing to comply with studyprocedures and appropriate dressing changes.

14. 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 the standard of care, ulcer size reduction is > 30% during thetwo-week run-in Screening Period (between the first Screening Visit/V0 andBaseline/V2 randomization).

2. Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitisshould be ruled out by clinical examination (probing of the wound) and X-rayfindings.

3. Presence of necrosis, purulence, or sinus tracts that cannot be removed bydebridement.

4. Laboratory values at Screening of:

5. White Blood Cells (WBC) < 3.0 X 109 cells/L, > 12.0 X 109 cells/L

6. C-Reactive Protein (CRP) >100 mg/L

7. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) andalanine transaminase (ALT)] > 3x the upper limit of normal

8. Albumin < 25 g/L

9. Renal function studies [Serum Creatinine] > 3x the upper limit of normal

10. Hemoglobin< 100 g/L

11. Presence of any clinically significant medical condition(s) in medical historyduring screening period that, in the opinion of the investigator, could interferewith wound healing, including but not limited to the following:

12. Acute or unstable Charcot foot

13. Current sepsis

14. Active malignant disease. A subject, who has had a malignant disease in thepast, was treated, and is currently disease-free, may be considered for studyentry.

15. Acquired immune deficiency syndrome (AIDS) or HIV positive.

16. Severe cerebrovascular lesion (acute or significant clinical manifestation) andsevere cardiac dysfunction (NYHA class III or IV) such as congestive heartfailure, myocardial infarction, or coronary artery bypass grafting, orpercutaneous transluminal coronary angioplasty was performed within the last 6months.

17. Subject is currently receiving (i.e., within 30 days of randomization visit) orscheduled to receive any of following medication or therapies, could interfere withwound healing during the study.

18. immunosuppressants (including chronic systemic and topical steroids)

19. cytotoxic chemotherapy

20. cytostatic therapy

21. negative pressure wound therapy

22. autoimmune disease therapy

23. dialysis

24. lower limb revascularization surgery

25. intravenous infusion of growth factors

26. use of any investigational drug(s)

27. Previous use of bioengineered tissue or skin substitutes on potential target ulcers.

28. Subjects who need to stand continuously for more than 4 hours / day and havedifficulty complying with off-loading instructions.

29. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol ordrug abuse, determined from the subject's medical history, which, in the opinion ofthe investigator, may pose a threat to subject compliance.

30. Has any other factor which may, in the opinion of the investigator, compromiseparticipation and/or follow-up in the study.