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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Messina

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