Diabetic FootPhase 3SitaDFUNCT02675335
Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
A Phase 3 study testing Sitagliptin in people with Diabetic Foot, run by Wolfgang-Michael Franz.
Trial summary
The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- Phase
- Phase 3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm
- stable size of the foot ulcer for at least 2 weeks
- HbA1c <= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones
Who cannot join
- local purulent signs of Inflammation at ulcer site
- planned interventional or surgical therapy of a macro vessel disease of the lower limb
- glomerular filtration rate <30ml/min
- liver cirrhosis CHILD B or C
- pregnancy, lactation
- allergy against Sitagliptin
- ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors
About this study
The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.
- Conditions
- Diabetic Foot
- Being tested
- Sitagliptin, Placebo
- Keywords
- Diabetic foot ulcer, Sitagliptin
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Chemical Abstracts Service (CAS) number 654671-77-9
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Sitagliptin tablets, 100mg per day, 12 weeks treatment Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | Placebo tablets, 1 tablet per day, 12 weeks treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean ulcer size after a treatment period of 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfgang-Michael Franz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wolfgang-Michael Franz, Medical University Innsbruck
- Investigators
- Wolfgang-M Franz, M.D., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675335
- Sponsor's protocol ID
- SitaDFU_v1.0
- Other IDs
- 2015-005226-19, MISP 52815, 2015
- Acronym
- SitaDFU
- Status last verified
- Sep 2016
- First submitted
- 3 Feb 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
- ClinicalTrials.gov ID
- NCT02675335
- Acronym / sponsor ID
- SitaDFU / SitaDFU_v1.0
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot ulcer, Sitagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wolfgang-Michael FranzUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 5 Feb 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.
The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: SitagliptinSitagliptin tablets, 100mg per day, 12 weeks treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets, 1 tablet per day, 12 weeks treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes mellitus
- at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm
- stable size of the foot ulcer for at least 2 weeks
- HbA1c <= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones
Key exclusion criteria (7 listed)
- local purulent signs of Inflammation at ulcer site
- planned interventional or surgical therapy of a macro vessel disease of the lower limb
- glomerular filtration rate <30ml/min
- liver cirrhosis CHILD B or C
- pregnancy, lactation
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 |
|---|---|---|
| SitagliptinAlso: Chemical Abstracts Service (CAS) number 654671-77-9 | Drug | Sitagliptin |
| Placebo | Drug | Placebo |
Primary outcome
mean ulcer size after a treatment period of 12 weeks
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
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.
Wolfgang-M Franz, M.D. principal investigator
Medical University Innsbruck
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin in people with Diabetic Foot, run by Wolfgang-Michael Franz.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Sep 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean ulcer size after a treatment period of 12 weeks (time frame: 12 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 15 Sep 2016.