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Diabetic Foot UlcerPhase 2/3NCT06531512

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

A Phase 2/3 study testing Xianglei Tangzu Gao in people with Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 14 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Xianglei Tangzu Gao
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
14 sitesChina
Study dates
16 Aug 2024to Aug 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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.
  • 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.
  • 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.
  • immunosuppressants (including chronic systemic and topical steroids)
  • cytotoxic chemotherapy
  • cytostatic therapy
  • negative pressure wound therapy
  • autoimmune disease therapy
  • dialysis
  • lower limb revascularization surgery
  • intravenous infusion of growth factors
  • use of any investigational drug(s)
  • Previous use of bioengineered tissue or skin substitutes on potential target ulcers.
  • Subjects who need to stand continuously for more than 4 hours / day and have difficulty complying with off-loading instructions.
  • 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.
  • Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Nanfang Hospital

    Guangzhou

  • Southern Medical University Third Hospital

    Guangzhou

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

    Guangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan

  • Huadong Hospital Affiliated to Fudan University

    Shanghai

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Shanghai TCM Integrated Hospital

    Shanghai

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

    Shenyang, Liaoning

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: 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

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.

Being tested
Xianglei Tangzu Gao, Vehicle Cream
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xianglei Tangzu GaoDrug

    Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

  • Vehicle CreamOther

    Cream base of Xianglei Tangzu Gao

Study groups in NCT06531512
Study groupRoleWhat they receive
Xianglei Tangzu Gao plus Standard of CareExperimentalXianglei Tangzu Gao will be applied twice daily for up to 16 weeks to the Target Ulcer.
Receives: Drug: Xianglei Tangzu Gao
Vehicle Cream plus Standard of CarePlacebo comparatorVehicle cream will be applied twice daily for up to 16 weeks to the Target Ulcer
Receives: Other: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16-week Treatment Phase

Secondary outcomes (3)

  1. Time to complete closure of Target Ulcer

    Time to complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by investigator.

    Measured: 16-week Treatment Phase

  2. The mean change for EQ-5D-5L score

    The mean change for EQ-5D-5L score between baseline to Day 57, 85, 113 and 197

    Measured: Day 57, 85, 113 and 197

  3. The proportion of subjects with complete closure of Target Ulcer

    The proportion of subjects with complete closure of Target Ulcer during the 16-week Treatment Phase, which is assessed by blinded independent review committee.

    Measured: 16-week Treatment Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start16 Aug 2024
  3. Primary completion8 May 2026
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06531512
Sponsor's protocol ID
ON101CLCT06
Status last verified
Jun 2026
First submitted
26 Jul 2024
Last updated
12 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Xianglei Tangzu Gao in people with Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with complete closure of Target Ulcer (time frame: 16-week Treatment Phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06531512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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