Diabetic Foot UlcerPhase 4DPP4iNCT02742233
Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
A Phase 4 study testing saxagliptin in people with Diabetic Foot Ulcer, run by Long Min,MD at 1 site in China.
Trial summary
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- saxagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2017
- Phase
- Phase 4
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
- Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)
- The subject agrees to comply with study protocol requirements and all follow up visit requirements.
Who cannot join
- Uncontrolled diabetes
- Ulcer infection
- Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
Hongting Zheng, Ph.D
About this study
Official title: A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
Read the detailed description
Groups:
Diabetic ulcers, saxagliptin + Regular treatment.
Diabetic ulcers, placebo + Regular treatment.
Time Point:
Initial treatment;
Post-treatment ( 1w );
Post-treatment ( 2w );
Post-treatment ( 4w );
Completely healed.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- saxagliptin, placebo
- Keywords
- Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saxagliptinDrug
Also called ONGLYZA
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.
Treatment Period: Participants will receive saxagliptin with regular treatment
placeboDrug
Also called dummy pills
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.
Treatment Period: Participants will receive placebo with regular treatment
| Study group | Role | What they receive |
|---|---|---|
| saxagliptin | Experimental | saxagliptin \& Regular treatment:
saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd Receives: Drug: saxagliptin |
| placebo | Placebo comparator | placebo \& Regular treatment:
placebo, dose: 5mg, po, qd Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completely healing time of the participants'target ulcer during the treatment period.
Complete ulcer closure is defined as 100% skin re-epithelialization
Measured: 16 weeks
Secondary outcomes (1)
Proportion of participants with complete healing during the treatment period.
Complete ulcer closure is defined as 100% skin re-epithelialization
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Long Min,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Long Min,MD, Xinqiao Hospital of Chongqing
- Investigators
- Hongting Zheng, Ph.D, Principal investigator, Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742233
- Sponsor's protocol ID
- XinqiaoH
- Acronym
- DPP4i
- Status last verified
- Jan 2017
- First submitted
- 24 Mar 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: age，the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT02742233
- Acronym / sponsor ID
- DPP4i / XinqiaoH
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Long Min,MDUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 Apr 2016 (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.
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
Detailed description
Groups:
Diabetic ulcers, saxagliptin + Regular treatment.
Diabetic ulcers, placebo + Regular treatment.
Time Point:
Initial treatment;
Post-treatment ( 1w );
Post-treatment ( 2w );
Post-treatment ( 4w );
Completely healed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saxagliptin | Experimental | Drug: saxagliptinsaxagliptin \& Regular treatment: saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd |
| placebo | Placebo comparator | Drug: placeboplacebo \& Regular treatment: placebo, dose: 5mg, po, qd |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
- Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)
- The subject agrees to comply with study protocol requirements and all follow up visit requirements.
Key exclusion criteria (3 listed)
- Uncontrolled diabetes
- Ulcer infection
- Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions
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 |
|---|---|---|
| saxagliptinAlso: ONGLYZAQualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment | Drug | saxagliptin |
| placeboAlso: dummy pillsQualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment | Drug | placebo |
Primary outcome
Completely healing time of the participants'target ulcer during the treatment period.
Time frame: 16 weeks
Complete ulcer closure is defined as 100% skin re-epithelialization
1 secondary outcome
Proportion of participants with complete healing during the treatment period.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Individual participant dataSharing planned: Yes. age，the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Hongting Zheng, Ph.D principal investigator
Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing saxagliptin in people with Diabetic Foot Ulcer, run by Long Min,MD 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 3 inclusion and 3 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 8 Aug 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Min Long, MD (023-68763255, longmin_casper@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completely healing time of the participants'target ulcer during the treatment period. (time frame: 16 weeks). 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 8 Aug 2017.