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

This study is currently recruiting participants.

Verified by University of Messina, February 2009

First Received: March 12, 2008 Last Updated: February 17, 2009 History of Changes

Sponsored by:	University of Messina
Information provided by:	University of Messina
ClinicalTrials.gov Identifier:	NCT00638872

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 Vasculopathic Ulcer	Drug: Polydeoxyribonucleotide Other: 0.9% NaCl	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

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 ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PDRN	Drug: Polydeoxyribonucleotide 3 times a week perilesional or intramuscular injections
placebo: 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.

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

Contacts

Contact: Domenico Cucinotta, MD

+390902212393

dcucinotta@unime.it

Locations

Italy
University of Messina	Recruiting
Messina, Italy, 98125
Contact: Domenico Cucinotta, MD +390902212393 dcucinotta@unime.it
Principal Investigator: Domenico Cucinotta, MD

Sponsors and Collaborators

University of Messina

Investigators

Study Director:

Giulia Cattarini

Mastelli srl, via Bussana Vecchia, Sanremo, Italy

More Information

No publications provided

Responsible Party:	Mastelli srl ( Mastelli srl )
Study ID Numbers:	PLA/01/06
Study First Received:	March 12, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00638872 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Messina:

diabetes
foot ulcer
polydeoxyribonucleotide

Study placed in the following topic categories:

Foot Ulcer
Ulcer
Diabetes Mellitus
Diabetic Foot

Additional relevant MeSH terms:

Pathologic Processes
Ulcer

ClinicalTrials.gov processed this record on September 10, 2009