Diabetic FootPhase 2NCT03574935
Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
A Phase 2 study testing External Chinese medicine and External Western medicine in people with Diabetic Foot and Ulcer, Skin, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot, Ulcer, Skin
- What is being tested?
- External Chinese medicine and External Western medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 30 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Diabetic Foot, Ulcer, Skin
- Being tested
- External Chinese medicine, External Western medicine
- Keywords
- "Qing-Hua-Bu", Dynamic sequential treatment, Clinical evaluation, Generalized application
- Medical subject headings
- Diabetic Foot, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Chinese medicineDrug
Also called "Qing-Hua-Bu" Three Dynamic Sequential Therapy
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.
External Western medicineDrug
Also called No.
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).
| Study group | Role | What they receive |
|---|---|---|
| External Chinese medicine | Experimental | 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. Receives: Drug: External Chinese medicine; Drug: External Western medicine |
| External Western medicine | Active comparator | 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. Receives: Drug: External Chinese medicine; Drug: External Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 56 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study chair, Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574935
- Sponsor's protocol ID
- 16411955000
- Status last verified
- Jun 2018
- First submitted
- 9 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer
- ClinicalTrials.gov ID
- NCT03574935
- Acronym / sponsor ID
- 16411955000
- Conditions
- Diabetic Foot, Ulcer, Skin
- Keywords
- "Qing-Hua-Bu", Dynamic sequential treatment, Clinical evaluation, Generalized application
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Chinese medicine | Experimental | Drug: External Chinese medicine, Drug: External Western medicineExternal 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 comparator | Drug: External Chinese medicine, Drug: External Western medicineEthacridine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Chinese medicineAlso: "Qing-Hua-Bu" Three Dynamic Sequential TherapyExternal 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. | Drug | External Chinese medicine, External Western medicine |
| External Western medicineAlso: No.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). | Drug | External Chinese medicine, External Western medicine |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Zhou study chair
Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External Chinese medicine and External Western medicine in people with Diabetic Foot and Ulcer, Skin, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulun Li (0086-021-65162629, drlifulun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing rate (time frame: up to 56 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.