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A single-center randomized double-blind placebo-controlled clinical study on the treatment of Wagner 2 diabetes ulcers with the traditional Chinese medicine Zizhu ointment for the promotion of granulation and the growth of new tissue

Registration number：

ITMCTR2025000118

Date of Last Refreshed on：

2025-01-22

Date of Registration：

2025-01-22

Registration Status：

Prospective registration

Public title：

A single-center randomized double-blind placebo-controlled clinical study on the treatment of Wagner 2 diabetes ulcers with the traditional Chinese medicine Zizhu ointment for the promotion of granulation and the growth of new tissue

English Acronym：

Scientific title：

A single-center randomized double-blind placebo-controlled clinical study on the treatment of Wagner 2 diabetes ulcers with the traditional Chinese medicine Zizhu ointment for the promotion of granulation and the growth of new tissue

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Hongshuo Shi

Study leader：

Weijing Fan

Applicant telephone：

17510413109

Study leader's telephone：

18811023202

Applicant Fax：

Study leader's fax：

Applicant E-mail：

jf17510413109@163.com

Study leader's E-mail：

fan18811023202@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

jf17510413109@163.com

Study leader's address：

fan18811023202@126.com

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-1621-204-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

RB of Shuguang Hospital affiliated with Shanghai University of TCM

Date of approved by ethic committee：

2024/11/13 0:00:00

Contact Name of the ethic committee：

Xi Geng

Contact Address of the ethic committee：

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine 528 Zhangheng Road Pudong New Area Shanghai.

Contact phone of the ethic committee：

021-20256070

Contact email of the ethic committee：

sgyyllwyh@126.com

Primary sponsor：

Shuguang Hospital Shanghai University of Traditional Chinese Medicine

Primary sponsor's address：

Shuguang Hospital Shanghai University of Traditional Chinese Medicine

Secondary sponsor：

Country：

China

Province：

shanghai

City：

Pudong New Area

Institution
hospital：

Shuguang Hospital Shanghai University of Traditional Chinese Medicine

Address：

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine 528 Zhangheng Road Pudong New Area Shanghai.

Source(s) of funding：

Shanghai Municipal Health Commission

Target disease：

diabetes ulcers

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

Using placebo as a control evaluate the efficacy and safety of the traditional Chinese medicine Zizhu ointment in treating Wagner 2 diabetes ulcers.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1.Men and women aged 118 to 65 2.Diagnosis record of type 21 or type 2 diabetes 3. Foot ulcer at or below the ankle lasting for >4 weeks to <1 year 4 meets the Wagner 2-stage diabetes ulcer diagnosis If there is more than one ulcer the largest ulcer is considered the target of the study 6. The target ulcer must be at least 1cm away from any other ulcer present on the foot 7. Research objective: The size of the ulcer after debridement at the beginning of the ulcer is ≥1 and ≤20cm2 8 patients with ABI>0.7 TcPO2>30 mmHg skin perfusion>30mmHg toe pressure>30 mmHg 9 Subject and caregiver are willing and able to comply with all specified care and visitation requirements 10. The subjects have reasonable expectations for completing the study

Exclusion criteria：

Gangrene occurs in any part of the affected limb. There is documented evidence of osteomyelitis in any part of the affected limb. Renal dialysis or creatinine levels >2.5 mg/dL (221 μmol/L). Use of chronic steroids or immunosuppressants within the past 3 months or anticipation of needing them during the study period. The subject has participated in another clinical drug study within the past 30 days. Patients who are allergic or intolerant to the study medication. Pregnant or lactating women or women at risk of pregnancy. Patients with severe cardiovascular and cerebrovascular diseases digestive system diseases endocrine system diseases neurological diseases etc. Patients with mental illness or depression. Situations deemed unsuitable for participation in this clinical trial by the researchers.

Study execute time：

From 2025-01-01

To      2025-06-30

Recruiting time：

From 2025-02-05

To      2025-04-30

Interventions：

77

Group：

control group

Sample size：

Intervention：

Placebo+basic treatment+wound management: routine debridement and dressing change

Intervention code：

77

Group：

trial group

Sample size：

Intervention：

Zizhu ointment+basic treatment+wound management: routine debridement and dressing change

Intervention code：

Total sample size ： 154

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Shuguang Hospital Shanghai University of Traditional Chinese Medicine

Level of the institution：

Level III Class A

Outcomes：

Outcome：

Incidence of osteomyelitis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM Symptom Score of diabetes Foot Ulcer

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Wound blood flow

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ulcer healing rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

transcutaneous oxygen pressure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Amputation rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ulcer recurrence rate (6-week follow-up)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Using the block randomization method and SAS statistical software a random number grouping table was generated and the subjects were randomly assigned to the experimental group and the control group in a 1:1 ratio.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The original data was released on January 1, 2027 and the public website is the China Clinical Trial Registration Platform located at http://itmctr.ccebtcm.org.cn

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic Medical Record Report Form (CRF): The data administrator designs and builds it based on the experimental plan and verifies it logically The plan (DVP) sets logical verification rules which are tested and approved by the sponsor before being released for use. Data entry: The CRF data is sourced from the original records and the data entry personnel will fill in the CRF instructions and Timely input of subject visit data into EDC. On site verification of source data (SDV): The inspector checks the consistency between CRF data and source data and if there are any questions Questions can be asked. Data Questions and Answers: The questions originate from the system questions of EDC logic verification which are monitored by inspectors and data administrators Researchers need to promptly answer artificial questions. Data administrators and inspectors provide approval for any questions if necessary You can raise questions again until the data is' clean '. Researcher's signature: After the data entry is completed and passed through SDV the researcher conducts an electronic signature review and confirmation. autograph If there are any data revisions in the future a new signature is required. Database locking: jointly signed by main researchers applicants statistical analysts and data management personnel After locking records in the database the data administrator locks the database. Database submission: The data administrator submits the database to the statistician. CRF archiving: The CRF of each subject is generated and saved as a PDF electronic document. Data management report: written by the data administrator. EDC shutdown: After the statistical analysis is completed the data administrator closes the database.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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