Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedJuly 2, 2018
June 1, 2018
1.2 years
June 9, 2018
June 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing rate
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.
up to 56 days after treatment
Study Arms (2)
External Chinese medicine
EXPERIMENTALExternal 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.
External Western medicine
ACTIVE COMPARATOREthacridine 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.
Interventions
External Chinese medicine: For patients in the treatment group, they will accept one of three specific External Chinese medicine according to their lesions and corresponding syndromes: 1. Chinese herb of "Clear heat-Remove dampness-Detoxicate" for patients belong to heat syndrome; 2. Chinese herb of "Activating blood-Removing stasis" for patients belong to stasis syndrome; 3. Chinese herb of "Supplement deficiency-Generate muscles" for patients belong to deficiency syndrome.
For patients in the control group, they will accept one of three specific external Western medicine according to their lesions: 1.Ethacridine Lactate Solution(lesions with much effusion)； 2.1% Sulfadiazine Silver Cream（lesions with infection）； 3.rb-bFGF(lesions with no slough and look clear).
Eligibility Criteria
You may qualify if:
- accord with standard of syndrome differentiation of traditional Chinese medicine and western medicine diagnostic criteria;
- age between 18-65 years old, gender, ethnic unlimited;
- agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
- sign the informed consent form and mark the date;
- If the patients are in the child-bearing period, they should accept the test of HCG and the result should be negative;
You may not qualify if:
- systematic application of steroids or immunosuppressor within 2 weeks;
- be allergic to any contents of known studied medicine;
- experiment results that may influence patients' safety;
- women within gestation period，suckling period or planning to gestation period;
- patients with severe heart, liver or kidney diseases;
- have received other studying medicine or taken part in other clinical experiments;
- cannot cooperate with the study for any reasons,such as language understanding and not able to see the doctors;
- other situations or diseases that researchers think may bring obvious risks to patients or interfere with the study results.
- cancer ulcer; tuberculotic ulcer；radioactive ulcer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Zhou
Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2018
First Posted
July 2, 2018
Study Start
July 1, 2018
Primary Completion
September 30, 2019
Study Completion
October 30, 2019
Last Updated
July 2, 2018
Record last verified: 2018-06