Accelerated wound healing in diabetic ulcers by Sitaglipti

Phase 1

Conditions: diabetic foot ulcer
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-005226-19-AT

Lead Sponsor: Medical University of Innsbruck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

-Typ 2 diabetic males and females > 18 years
-= 1 diabetic foot ulcer measuring 1-20 cm2,
-stable foot ulcer size over a period of = 2 weeks
-HbA1c = 8% on treatment with insulin, metformin, sulfonylurea, SGLT-2 inhibitors, glinids, glitazones (single or combination therapy)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

-local signs of purulent infection at ulcer site
-planned interventional or surgical treatment of a macrovascular disease in the lower limbs
-GFR<30 ml/min
-Ongoing treatment with DPP-IV antagonists
-Liver cirrhosis Child B, C
-Pregnancy, Lactation
-Allergy against Sitagliptin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of Sitagliptin on healing of stable, non-healing diabetic foot ulcers.<br>Quantification of ulcer size will be measured from baseline to 3 months follow-up using planimetry of the wound to compare the difference in mean ulcer size between treatment groups. <br>;Secondary Objective: To compare between treatment groups<br>-the difference in trans-cutaneous oxygen pressure (tcpO2) between baseline measurement and after 6 and 12 weeks of study treatment<br>-the changes in VEGF plasma levels between baseline and 12 weeks treatment<br>-the difference in migration capacity of isolated autologous blood monocytes at baseline and 12 weeks treatment<br>;Primary end point(s): ulcer size;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): tcpO2<br>VEGF Level<br>ABM Migration<br>SDF1<br>DPP$<br>TF Assay<br>HbA1c<br>blood lipids<br>CRP;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment