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

Primary Purpose

Diabetic Foot, Ulcer, Skin

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

External Chinese medicine

External Western medicine

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring "Qing-Hua-Bu", Dynamic sequential treatment, Clinical evaluation, Generalized application

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

External Chinese medicine

External Western medicine

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03574935

First Posted

June 9, 2018

Last Updated

June 29, 2018

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03574935

Brief Title

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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2018 (Anticipated)

Primary Completion Date

September 30, 2019 (Anticipated)

Study Completion Date

October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Yueyang Integrated Medicine Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot, Ulcer, Skin

Keywords

"Qing-Hua-Bu", Dynamic sequential treatment, Clinical evaluation, Generalized application

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

External Chinese medicine

Arm Type

Experimental

Arm Description

Arm Title

External Western medicine

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

External Chinese medicine

Other Intervention Name(s)

"Qing-Hua-Bu" Three Dynamic Sequential Therapy

Intervention Description

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: Chinese herb of "Clear heat-Remove dampness-Detoxicate" for patients belong to heat syndrome; Chinese herb of "Activating blood-Removing stasis" for patients belong to stasis syndrome; Chinese herb of "Supplement deficiency-Generate muscles" for patients belong to deficiency syndrome.

Intervention Type

Drug

Intervention Name(s)

External Western medicine

Other Intervention Name(s)

No.

Intervention Description

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).

Primary Outcome Measure Information:

Title

Wound healing rate

Description

Time Frame

up to 56 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fulun Li

Phone

0086-021-65162629

drlifulun@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Minfeng Wu

Phone

0086-021-50690332

996392167@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia Zhou

Organizational Affiliation

Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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