Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Foot Ulcers

Keywords

type 2 diabeteshealingfoot ulcersvildagliptin

Outcome Measures

Primary Outcomes (2)

Full Epithelialization of the Wound
Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome. Optic microscopy is used to evaluate the epithelialization of the wound.
3 months of treatment with vildagliptin
Capillary Density
Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome. Capillary density is measured using immunohistochemistry
3 months of treatment with vildagliptin

Secondary Outcomes (4)

HIF-1α
3 months
VEGF
3 months
VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)
3 months
iNOS
3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.

Drug: Placebo

Vildagliptin

EXPERIMENTAL

The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months

Drug: vildagliptin

Interventions

PlaceboDrug

Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea

Placebo

vildagliptinDrug

50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea

Vildagliptin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes
Oral hypoglycemic agents treatment

Sponsors & Collaborators

University of Campania Luigi Vanvitelli
Otherlead

Study Sites (1)

Second university of Naples

Naples, I-80100, Italy

Related Publications (1)

Marfella R, Sasso FC, Rizzo MR, Paolisso P, Barbieri M, Padovano V, Carbonara O, Gualdiero P, Petronella P, Ferraraccio F, Petrella A, Canonico R, Campitiello F, Della Corte A, Paolisso G, Canonico S. Dipeptidyl peptidase 4 inhibition may facilitate healing of chronic foot ulcers in patients with type 2 diabetes. Exp Diabetes Res. 2012;2012:892706. doi: 10.1155/2012/892706. Epub 2012 Nov 1.
PMID: 23197976RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Foot Ulcer

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Dr Raffaele Marfella
Organization: Second University Naples

Study Officials

Raffaele Marfella, MD, PhD
Second University Naples
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

106 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 16, 2011

Study Start

May 2011

Date type not reported

This date has not been verified as actual or estimated.

DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Results Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Placebo

Vildagliptin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Results Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Placebo

Vildagliptin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations