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

NCT01472432 | Completed Phase 4 Results

• 1 other identifier: IT 345461
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.

Conditions

Chronic Foot Ulcers

Keywords

type 2 diabetes; healing; foot ulcers; vildagliptin

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

Placebo DRUG

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

Placebo

vildagliptin DRUG

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Oral hypoglycemic agents treatment
• Chronic foot ulcers
• Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test \>30 -mmHg, anklebrachial index values \> 0.7 and \< 1.2 with toe pressure \> 30 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg
• Written consensus

You may not qualify if:

• Active Charcot disease
• Ulcers resulting from electrical, chemical, or radiation burns
• Collagen vascular disease
• Ulcer malignancy
• Untreated osteomyelitis, or cellulitis
• Ulcer treatment with normothermic or hyperbaric oxygen therapy
• Concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy
• Recombinant or autologous growth factor products
• Skin and dermal substitutes within 30 days of study start
• Use of any enzymatic debridement treatments
• Pregnant or nursing mothers

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Second university of Naples

Naples, I-80100, Italy

Location

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: 23197976 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Foot Ulcer

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Raffaele Marfella
• Organization: Second University Naples

raffaele.marfella@unina2.it

++390815665110

Study Officials

• Raffaele Marfella, MD, PhD

  Second University Naples

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 11, 2016
• Results First Posted: June 4, 2015

Record last verified: 2016-08

Locations

IT (1)