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Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin (SitaDFU)

Primary Purpose

Diabetic Foot

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Sponsored by
Wolfgang-Michael Franz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot ulcer, Sitagliptin

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Sitagliptin

    Placebo

    Arm Description

    Sitagliptin tablets, 100mg per day, 12 weeks treatment

    Placebo tablets, 1 tablet per day, 12 weeks treatment

    Outcomes

    Primary Outcome Measures

    mean ulcer size after a treatment period of 12 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2016
    Last Updated
    September 14, 2016
    Sponsor
    Wolfgang-Michael Franz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02675335
    Brief Title
    Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
    Acronym
    SitaDFU
    Official Title
    Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Wolfgang-Michael Franz

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot
    Keywords
    Diabetic foot ulcer, Sitagliptin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin
    Arm Type
    Active Comparator
    Arm Description
    Sitagliptin tablets, 100mg per day, 12 weeks treatment
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablets, 1 tablet per day, 12 weeks treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    Chemical Abstracts Service (CAS) number 654671-77-9
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    mean ulcer size after a treatment period of 12 weeks
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wolfgang-M Franz, M.D.
    Organizational Affiliation
    Medical University of Innsbruck
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

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