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A multi-center randomized parallel controlled study clinical trial protocol of badushengjisan for diabetes foot ulceration

A multi-center randomized parallel controlled study clinical trial protocol of badushengjisan for diabetes foot ulceration

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052646
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-12-30
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

diabetes foot ulceration

Interventions

Observation group: badushengjisan
control group:Sulfadiazine silver cream

Sponsors

Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~80 years; 2. The glycosylated hemoglobin HbA1c = 20mmhg or the ratio of ankle artery to brachial artery blood pressure is 0.5 = 2 cm2 and <= 30 cm2; 6. Good compliance, signed informed consent, and judged by the researcher to be eligible for enrollment.

Exclusion criteria

Exclusion criteria: 1. Severe ischemia, infection or local necrosis of limbs, requiring vascular bypass or interventional treatment or amputation; 2. Patients with multiple ulcer lesions or deep ulcers, accompanied by wound sinus or fistula, or requiring surgical treatment on the limb of the proposed test side; 3. Patients with other infectious diseases, severe primary diseases and mental illness; 4. Severe abnormal heart function, liver function, kidney function (cardiac function NYHA grade >= 3, alanine aminotransferase > 2.5 times of the normal control value, serum creatinine > 1.5 times of the normal control value), or other organ functions; 5. Malnutrition, hemoglobin < 90 g/L, serum albumin < 30 g/L; 6. Allergic constitution or allergic to any component of the test drug; 7. The researchers believed that the subjects had potential risks or any other factors that might interfere with the subjects.

Design outcomes

Primary

MeasureTime frame
Total effective rate;

Secondary

MeasureTime frame
The rate of wound healing;The time required for complete granulation of the wound;Time required for complete epithelialization of the wound;

Countries

China

Contacts

Public ContactFu xiaobing, Jiang yufeng, Li Binghui

Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

libinghui2006@sina.com+86 13871203981

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026