Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin | NCT02675335

Studies
Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

NCT02675335

Sponsor

Wolfgang-Michael Franz

Status

Withdrawn

Last Update Posted

Sep 15, 2016Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Diabetic Foot

Interventions

Sitagliptin
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-005226-19	EudraCT Number
MISP 52815	Other Identifier	Merck Investigator Studies Program

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 3, 2016

First Submission Date that Met QC Criteria

Feb 3, 2016

First Posted Date

Feb 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2016

Last Update Posted Date

Sep 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin	Active Comparator	Sitagliptin tablets, 100mg per day, 12 weeks treatment	Drug: Sitagliptin
Placebo	Placebo Comparator	Placebo tablets, 1 tablet per day, 12 weeks treatment	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin	Drug		Sitagliptin	Chemical Abstracts Service (CAS) number 654671-77-9

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean ulcer size after a treatment period of 12 weeks		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang-M Franz, M.D.	Medical University Innsbruck	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided