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

This study has been completed.
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina Identifier:
First received: March 12, 2008
Last updated: September 10, 2012
Last verified: September 2012
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

Condition Intervention Phase
Diabetic Ulcer Foot Ulcer Unhealed Drug: Polydeoxyribonucleotide Other: 0.9% NaCl Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Francesco Squadrito, University of Messina:

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

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

Enrollment: 215
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections
Placebo Comparator: placebo
Other: 0.9% NaCl
same as PDRN

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00638872

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

Responsible Party: Francesco Squadrito, Full Professor of Pharmacology, University of Messina Identifier: NCT00638872     History of Changes
Other Study ID Numbers: PLA/01/06
Study First Received: March 12, 2008
Last Updated: September 10, 2012

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

Additional relevant MeSH terms:
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer processed this record on September 21, 2017