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Clinical Study for the 'same disease treated by different remedies' Comprehensive Scheme in the Treatment of Diabetic Foot Disease

Clinical Study for the 'same disease treated by different remedies' Comprehensive Scheme in the Treatment of Diabetic Foot Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002988
Enrollment
Unknown
Registered
2020-02-09
Start date
2018-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Diabetic foot disease

Interventions

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Those who met the diagnostic criteria of Western medicine; 2. Wagner grade II-IV; 3. Those who met the diagnostic criteria of traditional Chinese medicine; 4. Aged 18-80 years old, male and female; 5. Those who had diabetic foot wound area (>1.2) and < 25.2 after debridement; 6. Those who had informed consent, signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who did not meet the diagnostic criteria and inclusion criteria; 2. Severe primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, psychiatric patients, cancer or AIDS patients; 1. Abnormal serum creatinine > 1.5 times the upper limit of normal value, proteinuria >+(>30mg/dl/100ml); 2. ALT > 1.5 times the upper limit of normal value; 3. arrhythmia of clinical significance; 4. pregnant or lactating women, allergic constitution; 5. patients with severe infection and critical condition; 6. patients with diabetic foot wound area after debridement (> 25cm2, or 2); 7. patients do not meet the inclusion criteria, do not use drugs according to regulations, can not judge the efficacy, or incomplete data affect the efficacy or safety judgment. According to the judgement of the researchers, other medical histories, such as frequent changes in working environment, which can reduce the possibility of enrollment or complicate enrollment, are liable to lead to loss of follow-up; 8. subjects who are participating in other drug clinical studies.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Secondary

MeasureTime frame
Wound healing rate;Rate of wound decay;TCM syndrome;Wound healing time;Amputation rate;Time of wound decay;Toe amputation rate (disability rate);mortality;Recurrence rate;

Countries

China

Contacts

Public ContactWang Yunfei
yunfeiww@126.com+86 18917763383

Outcome results

None listed

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