Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin (SitaDFU)

September 14, 2016 updated by: Wolfgang-Michael Franz
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sitagliptin
Sitagliptin tablets, 100mg per day, 12 weeks treatment
Drug: Sitagliptin
Other Names:
  • Chemical Abstracts Service (CAS) number 654671-77-9
Placebo Comparator: Placebo
Placebo tablets, 1 tablet per day, 12 weeks treatment
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfgang-Michael Franz

Investigators

  • Principal Investigator: Wolfgang-M Franz, M.D., Medical University of Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SitaDFU_v1.0
  • 2015-005226-19 (EudraCT Number)
  • MISP 52815 (Other Identifier: Merck Investigator Studies Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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