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

Primary Purpose

Diabetic Ulcer, Foot Ulcer Unhealed

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Polydeoxyribonucleotide
0.9% NaCl
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ulcer focused on measuring diabetes, foot ulcer, polydeoxyribonucleotide

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Messina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

placebo

Arm Description

PDRN

placebo

Outcomes

Primary Outcome Measures

reduction of ulcer rate

Secondary Outcome Measures

safety and tolerability of the compound

Full Information

First Posted
March 12, 2008
Last Updated
September 10, 2012
Sponsor
University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT00638872
Brief Title
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
Official Title
Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ulcer, Foot Ulcer Unhealed
Keywords
diabetes, foot ulcer, polydeoxyribonucleotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PDRN
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Polydeoxyribonucleotide
Intervention Description
3 times a week perilesional or intramuscular injections
Intervention Type
Other
Intervention Name(s)
0.9% NaCl
Intervention Description
same as PDRN
Primary Outcome Measure Information:
Title
reduction of ulcer rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
safety and tolerability of the compound
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulia Cattarini
Organizational Affiliation
Mastelli srl, via Bussana Vecchia, Sanremo, Italy
Official's Role
Study Director
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy

12. IPD Sharing Statement

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

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