Completed

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

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What is being tested

Polydeoxyribonucleotide

+ 0.9% NaCl

DrugOther
Who is being recruted

Diabetes Mellitus+8

+ Endocrine System Diseases

+ Foot Diseases

From 45 to 80 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: October 2007
See protocol details

Summary

Principal SponsorUniversity of Messina
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleDiabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
NCT00638872
Principal SponsorUniversity of Messina
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

215 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesFoot DiseasesLeg UlcerMetabolic DiseasesNutritional and Metabolic DiseasesSkin DiseasesSkin UlcerFoot UlcerSkin and Connective Tissue DiseasesGlucose Metabolism Disorders

Criteria

9 inclusion criteria required to participate
TcPO2 >29mmHg
Male or female aged 45-80yrs
Minimum schooling 5yrs
Type I or II diabetes since at least 5yrs with a stable metabolic control
Show More Criteria
12 exclusion criteria prevent from participating
Non-consenting patient
History of alcohol or drug abuse
Gangrene on any part of the affected foot
Ongoing untreated infections
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
PDRN

Group II

Placebo
placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Messina

Messina, ItalyOpen University of Messina in Google Maps
CompletedOne Study Center