NCT02675335

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

February 3, 2016

Last Update Submit

September 14, 2016

Conditions

Diabetic Foot

Keywords

Diabetic foot ulcer, Sitagliptin

Outcome Measures

Primary Outcomes (1)

  • mean ulcer size after a treatment period of 12 weeks

    12 weeks

Study Arms (2)

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

SitagliptinDRUG
Also known as: Chemical Abstracts Service (CAS) number 654671-77-9
Sitagliptin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Wolfgang-M Franz, M.D.

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 5, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share