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

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Unknown; Phase 2

Conditions: Ulcer, Skin; Diabetic Foot

Treatments: Drug: External Chinese medicine; Drug: External Western medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03574935

16411955000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

External Chinese medicine

Experimental group

Description:

External Chinese medicine include 3 kinds of formula，including: Qin, Hua and Bu will be applied to cover the participants' lesions in wet dressing form. Dosage form:5g/ml; frequency:qd; duration:2months.

Treatment:

Drug: External Western medicine

Drug: External Chinese medicine

External Western medicine

Active Comparator group

Description:

Ethacridine Lactate Solution, 1% Sulfadiazine Silver Cream and rb-bFGF will be applied to cover the participants' lesions. Dosage form:3g/ml; frequency:qd; duration: 2months.

Treatment:

Drug: External Western medicine

Drug: External Chinese medicine