Diabetic Foot UlcerPhase 2NCT00839865
Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer
A Phase 2 study testing herb ointment in people with Diabetic Foot Ulcer, run by Guiyang No.1 People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- herb ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-patient or out-patient patients diagnosed with diabetic foot ulcers
- Gangrene or ulceration occurred more than 3 weeks
- Over 18 years of age
- Gender-open
- The type of diabetes (type 1 or type 2) open
- Patients receive a written informed consent to participate in the trial
Who cannot join
- Serious complications of heart, liver, lung, kidney damage
- Malignant tumors
- Allergy for Chinese medicine used
- Pregnant women and breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
endocrinology unit,No.1 people's hospital of Guiyang City
Guiyang, Guizhou, 550002
Li ShuFa, Doctor, +86 0851 5833059, shufali@163.com
Liu JianPing, Doctor, +86 13718004410, jianping_l@hotmail.com
About this study
Official title: Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.
Read the detailed description
- Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
- Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
- extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
- comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
- we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety
- Conditions
- Diabetic Foot Ulcer
- Being tested
- herb ointment
- Keywords
- Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herb ointmentDrug
Also called TANGZUYUYANGGAO
a kind of ointment made from herb
| Study group | Role | What they receive |
|---|---|---|
| herb ointment dressing change group | Experimental | This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months Receives: Drug: herb ointment |
| Conventional dressing change group | No intervention | This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
Measured: 6 months
Secondary outcomes (1)
Secondary objectives include: evaluating the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and it's safety.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiyang No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Third Military Medical University
- Investigators
- Li Shufa, doctor, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839865
- Sponsor's protocol ID
- SFL-2008-11
- Other IDs
- ISRCTN20081114, NCI-197-4128D, R01-020225-1
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
Leung PC, Wong MW, Wong WC. Limb salvage in extensive diabetic foot ulceration: an extended study using a herbal supplement. Hong Kong Med J. 2008 Feb;14(1):29-33.
PubMed 18239240
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT00839865
- Acronym / sponsor ID
- SFL-2008-11
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guiyang No.1 People's HospitalUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Third Military Medical University
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- 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.
The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.
Detailed description
- Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
- Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
- extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
- comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
- we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herb ointment dressing change group | Experimental | Drug: herb ointmentThis group of patients in the ointment dressing every 2 days until Wound Healing or 6 months |
| Conventional dressing change group | No intervention | –This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In-patient or out-patient patients diagnosed with diabetic foot ulcers
- Gangrene or ulceration occurred more than 3 weeks
- Over 18 years of age
- Gender-open
- The type of diabetes (type 1 or type 2) open
Key exclusion criteria (4 listed)
- Serious complications of heart, liver, lung, kidney damage
- Malignant tumors
- Allergy for Chinese medicine used
- Pregnant women and breast-feeding women
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 |
|---|---|---|
| herb ointmentAlso: TANGZUYUYANGGAOa kind of ointment made from herb | Drug | herb ointment dressing change group |
Primary outcome
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
Time frame: 6 months
1 secondary outcome
Secondary objectives include: evaluating the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and it's safety.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
- Background: PubMed 18239240Leung PC, Wong MW, Wong WC. Limb salvage in extensive diabetic foot ulceration: an extended study using a herbal supplement. Hong Kong Med J. 2008 Feb;14(1):29-33.
Related trials for Diabetic Foot Ulcer
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Li Shufa, doctor study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herb ointment in people with Diabetic Foot Ulcer, run by Guiyang No.1 People's Hospital at 1 site in China.
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 6 inclusion and 4 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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Li Shufa, Doctor (+86 13885007886, shufali@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00839865, which also lists 1 linked publication.
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 10 Feb 2009.