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

NCT06531512 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ON101CLCT06
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 16

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with complete closure of Target Ulcer

  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.

  16-week Treatment Phase

Secondary Outcomes (3)

• Time to complete closure of Target Ulcer

  16-week Treatment Phase

• The mean change for EQ-5D-5L score

  Day 57, 85, 113 and 197

• The proportion of subjects with complete closure of Target Ulcer

  16-week Treatment Phase

Study Arms (2)

Xianglei Tangzu Gao plus Standard of Care

EXPERIMENTAL

Xianglei Tangzu Gao will be applied twice daily for up to 16 weeks to the Target Ulcer.

Drug: Xianglei Tangzu Gao

Vehicle Cream plus Standard of Care

PLACEBO COMPARATOR

Vehicle cream will be applied twice daily for up to 16 weeks to the Target Ulcer

Other: Vehicle Cream

Interventions

Xianglei Tangzu Gao DRUG

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

Xianglei Tangzu Gao plus Standard of Care

Vehicle Cream OTHER

Cream base of Xianglei Tangzu Gao

Vehicle Cream plus Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject has a glycosylated hemoglobin, HbA1c ≤ 12%.
• 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.
• An ulcer of Wagner Grade II.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• Ulcer size (area) is \> 1 cm2 and ≤ 25 cm2 (post-debridement at time of screening and randomization)
• Ulcer is located on or below the malleoli and presents duration of between 4 weeks and 12 months (at time of screening).
• 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).
• 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.
• 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).
• Subject should be able to walk and stand on the non-target ulcer limb.
• Subject is willing to use an off-loading device for the target ulcer on the plantar while ambulation for the duration of the study
• Subject and/or trained identified caregiver is able and willing to comply with study procedures and appropriate dressing changes.
• A signed and dated informed consent form has been obtained from the subject prior to any study-related procedures being performed.

You may not qualify if:

• 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).
• 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.
• Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
• Laboratory values at Screening of:
• White Blood Cells (WBC) \< 3.0 X 109 cells/L, \> 12.0 X 109 cells/L
• C-Reactive Protein (CRP) \>100 mg/L
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 25 g/L
• Renal function studies \[Serum Creatinine\] \> 3x the upper limit of normal
• Hemoglobin\< 100 g/L
• 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:
• Acute or unstable Charcot foot
• Current sepsis
• 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.
• Acquired immune deficiency syndrome (AIDS) or HIV positive.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (16)

Jiangmen Central Hospital

Jiangmen, Guangdong, China

RECRUITING

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

WITHDRAWN

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

RECRUITING

Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine)

Shenyang, Liaoning, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Nanfang Hospital

Guangzhou, China

RECRUITING

Southern Medical University Third Hospital

Guangzhou, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

Huadong Hospital Affiliated to Fudan University

Shanghai, China

RECRUITING

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Shanghai TCM Integrated Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Guang Ning

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Ho

CONTACT

+886 2 2703 1098; jessica.ho@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 1, 2024
• Study Start: August 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)