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

September 10, 2012 updated by: Francesco Squadrito, University of Messina

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98125
        • University of Messina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Other: 0.9% NaCl
same as PDRN
EXPERIMENTAL: 1
PDRN
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of ulcer rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of the compound
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Investigators

  • Study Director: Giulia Cattarini, Mastelli srl, via Bussana Vecchia, Sanremo, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (ESTIMATE)

March 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLA/01/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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