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

Launched by UNIVERSITY OF MESSINA · Mar 18, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged 45-80yrs
• • Minimum schooling 5yrs
• • Type I or II diabetes since at least 5yrs with a stable metabolic control
• • Foot ulcer since minimum 2 weeks
• • Ulcer \>1cm and \<16cm at day 0
• • Ulcer grade 1 or 2 wagner scale
• • Wound free of necrotic debris
• • TcPO2 \>29mmHg
• • Not pregnant or lactant
• Exclusion Criteria:
• • Non-consenting patient
• • History of alcohol or drug abuse
• • Gangrene on any part of the affected foot
• • Ongoing untreated infections
• • Ulcer over a charcot deformity
• • Use of a systemic cicatrizant drug in the past 10 days
• • Malnutrition
• • Neurological or psychiatric pathologies
• • Liver or kidney insufficiency
• • Corticosteroid or immunosuppressive or cytotoxic therapy
• • Other severe pathologies
• • Proven hypersensitivity to the drug or to any related component