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Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT02015910
Recruitment Status : Terminated (Terminated by the sponsor due to slow enrollment)
First Posted : December 19, 2013
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University

Brief Summary:

The primary objective of this study is to compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.

The hypothesis for this study is that subjects receiving daily doses of sitagliptin in combination with their regular antihyperglycemic medications will result in increased healing rates as well as a greater number of healed wounds as compared to subjects receiving placebo and their regular antihyperglycemic medications.


Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: Sitagliptin Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Januvia (Sitagliptin)
Sitagliptin 100 mg a day for 12 weeks
Drug: Sitagliptin
Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
Other Name: Januvia
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Sugar pill manufactured to mimick Sitagliptin 100mg pill.



Primary Outcome Measures :
  1. Percent Wounds Healed [ Time Frame: 12 weeks ]
    Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age >18
  • Type II Diabetes with glycated hemoglobin (hemoglobin A1C) of < 11
  • Currently on an oral hyperglycemic medication other than sitagliptin
  • A chronic wound defined as the lack of wound healing progress of <15% per week or 50% over a month period
  • Ankle brachial index of > 0.80
  • Wound located on the foot or ankle (Wagner Grade 1,2)
  • Able to comply with the requirements of the research trial

Exclusion Criteria:

  • Current use of dipeptidyl-peptidase four (DPP-4) inhibitor or glucagon like peptide one (GLP-1)agonist
  • End stage renal disease
  • Currently enrolled in another research trial that involves treatment of the wound
  • Active infection of the wound
  • Wound that probes to bone with osteomyelitis (Wagner Grade 3)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015910


Locations
United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Paul J Kim, DPM Georgetown University

Responsible Party: Paul J. Kim, DPM, Doctor of Podiatric Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT02015910     History of Changes
Other Study ID Numbers: MISP-RC50959
First Posted: December 19, 2013    Key Record Dates
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data was not collected for use in future research and will not be shared.

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action