Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT03574935
Status:
UNKNOWN
Last Update Posted:
2018-07-02
First Post:
2018-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D012883', 'term': 'Skin Ulcer'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2018-06-09', 'studyFirstSubmitQcDate': '2018-06-29', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing rate', 'timeFrame': 'up to 56 days after treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['"Qing-Hua-Bu"', 'Dynamic sequential treatment', 'Clinical evaluation', 'Generalized application'], 'conditions': ['Diabetic Foot', 'Ulcer, Skin']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethod: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. accord with standard of syndrome differentiation of traditional Chinese medicine and western medicine diagnostic criteria;\n2. age between 18-65 years old, gender, ethnic unlimited;\n3. agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;\n4. sign the informed consent form and mark the date;\n5. If the patients are in the child-bearing period, they should accept the test of HCG and the result should be negative;\n\nExclusion Criteria:\n\n1. systematic application of steroids or immunosuppressor within 2 weeks;\n2. be allergic to any contents of known studied medicine;\n3. experiment results that may influence patients' safety;\n4. women within gestation period，suckling period or planning to gestation period;\n5. patients with severe heart, liver or kidney diseases;\n6. have received other studying medicine or taken part in other clinical experiments;\n7. cannot cooperate with the study for any reasons,such as language understanding and not able to see the doctors;\n8. other situations or diseases that researchers think may bring obvious risks to patients or interfere with the study results.\n9. cancer ulcer; tuberculotic ulcer；radioactive ulcer"}, 'identificationModule': {'nctId': 'NCT03574935', 'briefTitle': 'Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Yueyang Integrated Medicine Hospital'}, 'officialTitle': 'Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer', 'orgStudyIdInfo': {'id': '16411955000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External Chinese medicine', 'description': "External Chinese medicine include 3 kinds of formula，including:\n\nQin, Hua and Bu will be applied to cover the participants' lesions in wet dressing form. Dosage form:5g/ml; frequency:qd; duration:2months.", 'interventionNames': ['Drug: External Chinese medicine', 'Drug: External Western medicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External Western medicine', '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.", 'interventionNames': ['Drug: External Chinese medicine', 'Drug: External Western medicine']}], 'interventions': [{'name': 'External Chinese medicine', 'type': 'DRUG', 'otherNames': ['"Qing-Hua-Bu" Three Dynamic Sequential Therapy'], 'description': 'External Chinese medicine:\n\nFor patients in the treatment group, they will accept one of three specific External Chinese medicine according to their lesions and corresponding syndromes:\n\n1. Chinese herb of "Clear heat-Remove dampness-Detoxicate" for patients belong to heat syndrome;\n2. Chinese herb of "Activating blood-Removing stasis" for patients belong to stasis syndrome;\n3. Chinese herb of "Supplement deficiency-Generate muscles" for patients belong to deficiency syndrome.', 'armGroupLabels': ['External Chinese medicine', 'External Western medicine']}, {'name': 'External Western medicine', 'type': 'DRUG', 'otherNames': ['No.'], 'description': 'For patients in the control group, they will accept one of three specific external Western medicine according to their lesions:\n\n1.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).', 'armGroupLabels': ['External Chinese medicine', 'External Western medicine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fulun Li', 'role': 'CONTACT', 'email': 'drlifulun@163.com', 'phone': '0086-021-65162629'}, {'name': 'Minfeng Wu', 'role': 'CONTACT', 'email': '996392167@qq.com', 'phone': '0086-021-50690332'}], 'overallOfficials': [{'name': 'Jia Zhou', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Yueyang Integrated Medicine Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}