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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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