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

Last updated: September 10, 2012
Sponsor: University of Messina
Overall Status: Completed

Phase

4

Condition

Diabetes And Hypertension

Ulcers

Treatment

N/A

Clinical Study ID

NCT00638872
PLA/01/06
  • Ages 45-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Total Participants: 215
Study Start date:
October 01, 2007
Estimated Completion Date:
December 31, 2011

Study 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.

Connect with a study center

  • University of Messina

    Messina, 98125
    Italy

    Site Not Available

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