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Study on evidence-based evaluation and therapeutic mechanism of integrated Chinese and Western medicine for treatment of diabetic foot -- An evidence-based evaluation of The combination of Rubber Shengji Paste and compound bromelain to promote the healing of the exposed wound of diabetic foot tendon

Study on evidence-based evaluation and therapeutic mechanism of integrated Chinese and Western medicine for treatment of diabetic foot -- An evidence-based evaluation of The combination of Rubber Shengji Paste and compound bromelain to promote the healing of the exposed wound of diabetic foot tendon

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039327
Enrollment
Unknown
Registered
2020-10-23
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot

Interventions

Sponsors

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Those who do not meet any of the following criteria will not be included in this study (1) Patients who meet the diagnostic criteria for diabetic foot diseases and Wagner grades 3-4 injuries and tendon tissues; (2) Between the ages of 18 and 85, male or female; (3) Fasting blood glucose = 0.5; (6) The wound has new blood supply or ooze, pus or secretions are sticky; (7) Participate in this experiment voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: Those who meet any of the following criteria will not be included in this study (1) Skin ulcers and malignant lesions in ulcer caused by electrical, chemical, radioactive, neoplastic, varicose veins and other reasons; (2) Severe clinical infection, such as cellulitis, fever or elevated white blood cells in blood routine, or bacterial culture or detection (hypersensitivity) of C-reactive protein indicated the presence of infected persons at the lesion site of the ulcer; (3) With severe uncontrolled hypertension, systolic blood pressure >= 160mmHg or diastolic blood pressure >= 110mmHg; (4) Serum albumin < 28g/L; (5) Hemoglobin < 90g/L; (6) Platelet < 50 x 10^9/L; (7) For patients with severe heart, liver and kidney injuries, those requiring medical treatment or those seriously affecting the safety and treatment of the subjects, the researcher shall decide whether to exclude them; (8) those who have pregnancy or family planning, or women who are pregnant or lactating; (9) People with cognitive dysfunction who cannot give full informed consent; (10) Persons with allergic constitution or known allergy to the ingredients of test drugs and control drugs; (11) Participate in other clinical trials within the past 1 month; (12) According to the judgment of the researcher, the patient cannot complete the study or comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
Granulation coverage of wound;

Secondary

MeasureTime frame
Wound healing rate;Granulation time;Maryland Foot Function Score;

Countries

China

Contacts

Public ContactZhang zhaohui

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

zzh45@aliyun.com+86 13920987708

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026