drugset / Trial / NCT03574935

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

NCT03574935

Phase 2 Unknown 150 enrolled Shanghai Yueyang Integrated Medicine Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-07-01
Primary completion
2019-09-30
Completion
2019-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ethacridine Lactate Small molecule Topical
Subject External Chinese medicine Traditional medicine (herbal / TCM) Topical
Subject Silver Sulfadiazine Small molecule Topical
Subject rb-bFGF Protein / enzyme biologic Topical

Indications