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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina
ClinicalTrials.gov Identifier:
NCT00638872
First received: March 12, 2008
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Messina:

Primary Outcome Measures:
  • reduction of ulcer rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

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
PDRN
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections
Placebo Comparator: placebo
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: March 12, 2008
Last Updated: September 10, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Messina:
diabetes
foot ulcer
polydeoxyribonucleotide

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

ClinicalTrials.gov processed this record on April 17, 2014