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

Phase 4

Completed

• Conditions: Diabetic Ulcer; Foot Ulcer Unhealed
• Interventions: Other: 0.9% NaCl; Drug: Polydeoxyribonucleotide

• Registration Number: NCT00638872
• Lead Sponsor: University of Messina

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-19
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	0.9% NaCl	placebo
1	Polydeoxyribonucleotide	PDRN

Primary Outcome Measures

Name	Time	Method
reduction of ulcer rate	3 months

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of the compound	6 months

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy