Status:
COMPLETED
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Chronic Foot Ulcers
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
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.
Detailed Description
The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in the developed world and is a major morbidity associated with diabetes, often leading to pain, suffering, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01472432
Start Date
May 1 2011
End Date
January 1 2016
Last Update
October 11 2016
Active Locations (1)
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1
Second university of Naples
Naples, Italy, I-80100