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

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ClinicalTrials.gov Identifier: NCT00638872
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina

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

Condition or disease Intervention/treatment Phase
Diabetic Ulcer Foot Ulcer Unhealed Drug: Polydeoxyribonucleotide Other: 0.9% NaCl Phase 4

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  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
Study Start Date : October 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
PDRN
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections
Placebo Comparator: placebo
placebo
Other: 0.9% NaCl
same as PDRN



Primary Outcome Measures :
  1. reduction of ulcer rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. safety and tolerability of the compound [ Time Frame: 6 months ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638872


Locations
Italy
University of Messina
Messina, Italy, 98125
Sponsors and Collaborators
University of Messina
Investigators
Study Director: Giulia Cattarini Mastelli srl, via Bussana Vecchia, Sanremo, Italy

Responsible Party: Francesco Squadrito, Full Professor of Pharmacology, University of Messina
ClinicalTrials.gov Identifier: NCT00638872     History of Changes
Other Study ID Numbers: PLA/01/06
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Francesco Squadrito, University of Messina:
diabetes
foot ulcer
polydeoxyribonucleotide

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer