Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the... | NCT00638872

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

NCT00638872

Sponsor

University of Messina

Status

Completed

Last Update Posted

Sep 11, 2012Estimated

Enrollment

215Actual

Phase

Phase 4

Conditions

Diabetic Ulcer
Foot Ulcer Unhealed

Interventions

Polydeoxyribonucleotide
0.9% NaCl

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2012

Last Update Posted Date

Sep 11, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PDRN	Drug: Polydeoxyribonucleotide
placebo	Placebo Comparator	placebo	Other: 0.9% NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polydeoxyribonucleotide	Drug	3 times a week perilesional or intramuscular injections	1

Measure	Description	Time Frame
reduction of ulcer rate		3 months

Measure	Description	Time Frame
safety and tolerability of the compound		6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giulia Cattarini	Mastelli srl, via Bussana Vecchia, Sanremo, Italy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Messina		Messina		98125	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D016523	Foot Ulcer

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011089	Polydeoxyribonucleotides
D000077330	Saline Solution

Ancestor Terms

ID	Term
D011119	Polynucleotides
D009711	Nucleotides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D000077324	Crystalloid Solutions

Browse Leaves

Not provided

Browse Branches

Not provided