Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Phase 3

Withdrawn

• Conditions: Diabetic Foot
• Interventions: Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT02675335
• Lead Sponsor: Wolfgang-Michael Franz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-05
• Study Start: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets, 1 tablet per day, 12 weeks treatment
Sitagliptin	Sitagliptin	Sitagliptin tablets, 100mg per day, 12 weeks treatment

Primary Outcome Measures

Name	Time	Method
mean ulcer size after a treatment period of 12 weeks	12 weeks