Clinical trial NCT03574935: Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
Official title: Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Foot
Ulcer, Skin
Keywords: "Qing-Hua-Bu"
Dynamic sequential treatment
Clinical evaluation
Generalized application
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Aim: Under guidance of "Clear pus-Remove stasis-Supplement muscles" theory, to observe clinical effectiveness of dynamic Chinese external therapy of "Qing-Hua-Bu" in treating diabetic ulcer and partially explain potential wound healing mechanism.

Method: Clinical observation: To adopt the design method of open and parallel control test and include 150 diabetic ulcer patients. The treatment group was supplied with external clearing heat, removing stasis and supplementing deficiency Chinese medicine, while the control group was supplied with sulfadiazine silver cream, furacilin solution and bovine basic fibroblast growth factors (b-FGF) spray. To perform the dressing change for wound every day and persist in dressing change for two months. To record dynamic wound healing progress by digital camera. After finishing course, to compare wound healing, pus, exudate, granulation tissues and epithelial tissues and analyze these data by SPSS22.0.

Eligibility 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

Primary outcomes:
measure: Wound healing rate
timeFrame: up to 56 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References: