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

NCT00638872 | Completed Phase 4 DMC

• 1 other identifier: PLA/01/06
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Ulcer; Foot Ulcer Unhealed

Keywords

diabetes; foot ulcer; polydeoxyribonucleotide

Outcome Measures

Primary Outcomes (1)

• reduction of ulcer rate

  3 months

Secondary Outcomes (1)

• safety and tolerability of the compound

  6 months

Study Arms (2)

1

EXPERIMENTAL

PDRN

Drug: Polydeoxyribonucleotide

placebo

PLACEBO COMPARATOR

placebo

Other: 0.9% NaCl

Interventions

Polydeoxyribonucleotide DRUG

3 times a week perilesional or intramuscular injections

1

0.9% NaCl OTHER

same as PDRN

placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Interventions

Polydeoxyribonucleotides; Saline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Giulia Cattarini

  Mastelli srl, via Bussana Vecchia, Sanremo, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pharmacology

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

IT (1)