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

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ClinicalTrials.gov Identifier: NCT03574935
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer, Skin Drug: External Chinese medicine Drug: External Western medicine Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: External Chinese medicine

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.

Drug: External Chinese medicine

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.
Other Name: "Qing-Hua-Bu" Three Dynamic Sequential Therapy

Drug: External Western medicine

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).

Other Name: No.

Active Comparator: External Western medicine
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.
Drug: External Chinese medicine

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.
Other Name: "Qing-Hua-Bu" Three Dynamic Sequential Therapy

Drug: External Western medicine

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).

Other Name: No.




Primary Outcome Measures :
  1. Wound healing rate [ Time Frame: up to 56 days after treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574935


Contacts
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Contact: Fulun Li 0086-021-65162629 drlifulun@163.com
Contact: Minfeng Wu 0086-021-50690332 996392167@qq.com

Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Investigators
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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

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03574935     History of Changes
Other Study ID Numbers: 16411955000
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
"Qing-Hua-Bu"
Dynamic sequential treatment
Clinical evaluation
Generalized application
Additional relevant MeSH terms:
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Diabetic Foot
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats