Phase 4
N=106
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Chronic Foot Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01472432 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Full Epithelialization of the Wound — 16; 8 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); vildagliptin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Campania Luigi Vanvitelli
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Epithelialization of the Wound |
16; 8 | <0.05 sig |
| PRIMARY Capillary Density |
50; 140; 48; 46 | <0.05 sig |
| SECONDARY HIF-1α |
200; 600; 205; 215 | <0.05 sig |
| SECONDARY VEGF |
200; 580; 210; 215 | <0.05 sig |
| SECONDARY VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form) |
— | — |
| SECONDARY iNOS |
— | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01472432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.