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

Diabetic Ulcer Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Ulcer
• Foot Ulcer
• Foot Ulcer Unhealed
• Ulcer

• NCT number: NCT00638872
• Study type: Interventional
• Source: University of Messina
• Status: Completed
• Phase: Phase 4
• Start date: October 2007
• Completion date: December 2011