Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer

• Status: Unknown status
• Trial end date: 2019-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This project is based on investigator team's ten year experience on diabetic ulcer and goes on further developing basic research and concluding clinical experience. The investigator team has recently developed "Remove stasis to generate granulation tissue" into "Remove slough to generate granulation tissue". Investigators have applied the principle of "Remove stasis" in the medium and later stage of treatment to make "Remove slough-Eliminate stasis-Generate granulation tissue" become the basic principle of three-stage sequential treatment. Investigators will further conclude Chinese medicine therapy in the stage of "Qing-Hua-Bu" and evaluate safety, applicability and availability of it. Therefore, the research can help improve clinical diagnosis and treatment technique and transfer the study result of Chinese medicine experience on diabetic ulcer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Criteria

Inclusion Criteria:

1. accord with standard of syndrome differentiation of traditional Chinese medicine and western medicine diagnostic criteria;

2. age between 18-65 years old, gender, ethnic unlimited;

3. agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;

4. sign the informed consent form and mark the date;

5. If the patients are in the child-bearing period, they should accept the test of HCG and the result should be negative;

Exclusion Criteria:

1. systematic application of steroids or immunosuppressor within 2 weeks;

2. be allergic to any contents of known studied medicine;

3. experiment results that may influence patients' safety;

4. women within gestation period，suckling period or planning to gestation period;

5. patients with severe heart, liver or kidney diseases;

6. have received other studying medicine or taken part in other clinical experiments;

7. cannot cooperate with the study for any reasons,such as language understanding and not able to see the doctors;

8. other situations or diseases that researchers think may bring obvious risks to patients or interfere with the study results.

9. cancer ulcer; tuberculotic ulcer；radioactive ulcer