Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Diabetic Foot Clinical Trial

— SitaDFU  

Official title:

Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02675335
• Other study ID #: SitaDFU_v1.0
• Secondary ID: 2015-005226-19MI
• Status: Withdrawn
• Phase: Phase 3
• First received: February 3, 2016
• Last updated: September 14, 2016
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: September 2016
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Drug:
• Sitagliptin

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfgang-Michael Franz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean ulcer size after a treatment period of 12 weeks		12 weeks	No