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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in dialysis patients This study aimed to evaluate the effects of a topical cream containing Plectranthus amboinicus and Centella Asiatica when applied topically to diabetic foot ulcers in uremia patients with PAOD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cathay General Hospital
• Collaborator: Oneness Biotech Co., Ltd.

Criteria

Inclusion Criteria:

1. Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.

2. Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.

3. Subjects maintain regular/stable blood purification treatment of hemodialysis (HD) or peritoneal dialysis (PD) for ≥6 months prior to Visit 0 (V0).

4. Presence of at least one diabetic foot ulcer that meets all of the following criteria:

1. A full-thickness ulcer of UTWCS Grade I-A or II-A

2. Ulcer size (area) is > 2 cm2 and ≤ 10 cm2 (post-debridement at time of enrollment)

3. Ulcer is located on or below the malleoli.

4. Ulcer presents for > 4 weeks (at time of enrollment).

5. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, (post-debridement).

6. 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 most severe ulcer will be designated as the target ulcer; meanwhile, the depth of the wound will the consideration prior to the area of the wound.

5. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-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 serious embolisms / no serious clogging of blood vessels. .

6. Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, 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, injectable, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and/or who have been sterilized).

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

8. Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures.

9. A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

Exclusion Criteria:

1. In response to standard of care, ulcer size reduction is > 30% during the two-week run-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:

1. Hemoglobin < 6.0 g/dL

2. White Blood Cells (WBC) < 3.0 X 103 cells/uL； > 12.0 X 103 cells/uL

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

4. Albumin < 2.5 g/dL

4. Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the investigator, could interfere with wound healing, including but not limited to the following:

1. Acute or unstable Charcot foot

2. 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.

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

5. Subject is currently receiving (i.e., within 30 days of enrollment visit) or scheduled to receive any of following medication or therapies, could interfere with wound healing during the course of the study.

1. immunosuppressant (including chronic systemic corticosteroids)

2. cytotoxic chemotherapy

3. cytostatic therapy

4. autoimmune disease therapy

5. growth factors

6. hyperbaric oxygen therapy

7. bioengineered tissue or skin substitutes（ADM）

8. application of topical steroids to the ulcer

9. use of any investigational drug(s)

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

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

Note ( Based on TEXAS 1A, 2A, the below information is to further calcification, and potential subjects meeting any of the following items will be excluded from the study.) :

1. Ulcers with exposed bone or associated with osteomyelitis. (The osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings as deemed necessary by the Investigator.)

2. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.

3. Current sepsis

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