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Study on TCM precise external treatment of refractory diabetic foot ulcer (Wagner grade 3-5)

Study on TCM precise external treatment of refractory Wagner3 ~ 5 diabetic foot ulcer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003745
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
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 ulcer

Interventions

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of diabetes mellitus; 2. Patients who met Wagner's grade 3-5 classification of diabetic foot; 3. Patients aged 45-85 years old; 4. Patients who agree to participate in randomized controlled trials and sign informed consent form by themselves or their guardians. Only those who meet the above requirements can be included.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with diabetic ketosis, ketoacidosis and severe infection in recent 3 months; 3. Patients with serious heart, liver and kidney complications, or with other serious primary diseases and mental patients; 4. Patients with neurovascular diseases caused by other reasons; 5. Patients who are allergic to the related drugs in the treatment plan and are not suitable for receiving the treatment plan; 6. Patients who are participating in other clinical trials; 7. Other situations that the researcher thinks are not suitable for the group. Those who meet the above requirements are excluded.

Design outcomes

Primary

MeasureTime frame
amputation rate;clinical efficacy;healing rate;

Secondary

MeasureTime frame
Lipid metabolism index;Glucose metabolism index;Lower limb CTA or MRA;Lower extremity artery ultrasound;Evaluation index of diabetic foot typing;Bacterial and fungal culture and drug susceptibility;Ankle-brachial ratio index;symptoms and signs;Quality of Life scale;Diabetic neuropathy and test scores;Foot X ray;Evaluation index of diabetic foot immunology;

Countries

China

Contacts

Public ContactLiu Guobin

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

15800885533@163.com+86 15800885533

Outcome results

None listed

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