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Clinical effect analysis and mechanism study on Qufu Shengjidan fo diabetic foot ulcer

Clinical effect analysis and mechanism study on Qufu Shengjidan for diabetic foot ulcer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032315
Enrollment
Unknown
Registered
2020-04-25
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-04-27

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

Chongqing Orthopaedic Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, gender unlimited; 2. Patients diagnosed with diabetes mellitus and ulceration, which accords with the classical Wagner grading method of grade 1-3; Grade 0: no open lesions, but belongs to high-risk foot; Grade 1: superficial ulcer with skin penetration; Grade 2: deeper ulcer, including ulcers of joints and tendons; Grade 3: deep ulcer, abscess formation, tendon ligament tissue damage; Grade 4: local gangrene and bone destruction; Grade 5: total foot gangrene. 3. Patients who did not use immunosuppressive agents, or those whose doses of immunosuppressive agents remained unchanged recently; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. diabetic ketoacidosis, non-ketotic hyperosmolar coma patients; 2. women in lactation and pregnancy; 3. patients with allergic history or recent allergic diseases to multiple drugs; 4. patients with severe cardiopulmonary disease, cirrhosis, diabetic nephropathy or more, whose condition is still unstable after active medical treatment; 5. ulcers caused by malignant tumors; 6. patients with psychiatric diseases and ignoranceThose who can not express exactly; 7. those with poor compliance; 8. those who have participated in other clinical trials of new drugs in the last three months.

Design outcomes

Primary

MeasureTime frame
Change of ulcer area;Clinical efficacy evaluation;Determination of inflammation-related indicators;

Secondary

MeasureTime frame
Observation of histochemical staining of granulation tissue;

Countries

China

Contacts

Public ContactShen Kaiqin

Chongqing Orthopaedic Hospital of Traditional Chinese Medicine

qiwei_ok@sina.com+86 13657684554

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026