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Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

This study has been terminated.
(Terminated by the sponsor due to slow enrollment)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University
ClinicalTrials.gov Identifier:
NCT02015910
First received: December 13, 2013
Last updated: November 8, 2016
Last verified: November 2016
  Purpose

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 Intervention Phase
Type II Diabetes Drug: Sitagliptin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paul J. Kim, DPM, Georgetown University:

Primary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: January 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 13, 2013
Results First Received: April 22, 2016
Last Updated: November 8, 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

ClinicalTrials.gov processed this record on September 20, 2017