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

Phase 2

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: Xianglei Tangzu Gao; Other: Vehicle Cream

• Registration Number: NCT06531512
• Lead Sponsor: Oneness Biotech Co., Ltd.

Brief Summary

This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Study Start: 2024-08-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

4. An ulcer of Wagner Grade II.

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

   1. Ulcer size (area) is > 1 cm2 and ≤ 25 cm2 (post-debridement at time of screening and randomization)
   2. Ulcer is located on or below the malleoli and presents duration of between 4 weeks and 12 months (at time of screening).
   3. If there are more than two ulcers, there should be a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post- debridement).
   4. 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. Severity will be determined by the investigator's assessment.

6. Subject, if a female of child-bearing potential, has a negative serum pregnancy test at 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 the study (excluding women who are not of childbearing potential and/or who have been sterilized).

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

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

9. Subject and/or trained identified caregiver is able and willing to comply with study procedures and appropriate dressing changes.

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

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

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

4. Laboratory values at Screening of:

   1. White Blood Cells (WBC) < 3.0 X 109 cells/L, > 12.0 X 109 cells/L
   2. C-Reactive Protein (CRP) >100 mg/L
   3. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
   4. Albumin < 25 g/L
   5. Renal function studies [Serum Creatinine] > 3x the upper limit of normal
   6. Hemoglobin< 100 g/L

5. 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. Current sepsis
   3. 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.
   4. Acquired immune deficiency syndrome (AIDS) or HIV positive.
   5. Severe cerebrovascular lesion (acute or significant clinical manifestation) and severe cardiac dysfunction (NYHA class III or IV) such as congestive heart failure, myocardial infarction, or coronary artery bypass grafting, or percutaneous transluminal coronary angioplasty was performed within the last 6 months.

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

   1. immunosuppressants (including chronic systemic and topical steroids)
   2. cytotoxic chemotherapy
   3. cytostatic therapy
   4. negative pressure wound therapy
   5. autoimmune disease therapy
   6. dialysis
   7. lower limb revascularization surgery
   8. intravenous infusion of growth factors
   9. use of any investigational drug(s)

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

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

9. 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xianglei Tangzu Gao plus Standard of Care	Xianglei Tangzu Gao	Xianglei Tangzu Gao will be applied twice daily for up to 16 weeks to the Target Ulcer.
Vehicle Cream plus Standard of Care	Vehicle Cream	Vehicle cream will be applied twice daily for up to 16 weeks to the Target Ulcer

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with complete closure of Target Ulcer	16-week Treatment Phase	The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by investigator.

Secondary Outcome Measures

Name	Time	Method
Time to complete closure of Target Ulcer	16-week Treatment Phase	Time to complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by investigator.
The mean change for EQ-5D-5L score	Day 57, 85, 113 and 197	The mean change for EQ-5D-5L score between baseline to Day 57, 85, 113 and 197
The proportion of subjects with complete closure of Target Ulcer	16-week Treatment Phase	The proportion of subjects with complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by blinded independent review committee.

Trial Locations

Locations (12)

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

The First Affiliated Hospital of Henan University of Science & Technology; 🇨🇳 Luoyang, Henan, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China

Nanfang Hospital; 🇨🇳 Guangzhou, China

Southern Medical University Third Hospital; 🇨🇳 Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

Huadong Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China

Longhua Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Shanghai TCM Integrated Hospital; 🇨🇳 Shanghai, China