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Completed

NCT Number: NCT00638872

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

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

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Key information

Conditions

Diabetic Ulcer Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Foot Ulcer Unhealed Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Messina

Messina, 98125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polydeoxyribonucleotide

Drug

3 times a week perilesional or intramuscular injections

0.9% NaCl

Other

same as PDRN

Primary outcomes

  1. reduction of ulcer rate

    Time frame: 3 months

Secondary outcomes

  1. safety and tolerability of the compound

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Mar 19, 2008
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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