NCT00638872

Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers

Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

Detailed description

This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.

Conditions

• Diabetic Ulcer
• Foot Ulcer Unhealed

Interventions

Type	Name	Description
DRUG	Polydeoxyribonucleotide	3 times a week perilesional or intramuscular injections
OTHER	0.9% NaCl	same as PDRN

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2008-03-19
• Last updated: 2012-09-11

Locations

1 site across 1 country: Italy