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

NCT ID: NCT00638872

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Ulcer Foot Ulcer Unhealed

Keywords

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diabetes foot ulcer polydeoxyribonucleotide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

PDRN

Group Type EXPERIMENTAL

Polydeoxyribonucleotide

Intervention Type DRUG

3 times a week perilesional or intramuscular injections

placebo

placebo

Group Type PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type OTHER

same as PDRN

Interventions

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Polydeoxyribonucleotide

3 times a week perilesional or intramuscular injections

Intervention Type DRUG

0.9% NaCl

same as PDRN

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Francesco Squadrito

Full Professor of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giulia Cattarini

Role: STUDY_DIRECTOR

Mastelli srl, via Bussana Vecchia, Sanremo, Italy

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PLA/01/06

Identifier Type: -

Identifier Source: org_study_id