Trial | NCT00638872  Report issue

Title

Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    215
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.
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.
Study Started
Oct 31
2007
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2011
Last Update
Sep 11
2012
Estimate

Drug Polydeoxyribonucleotide

3 times a week perilesional or intramuscular injections

Other 0.9% NaCl

same as PDRN

1 Experimental

PDRN

placebo Placebo Comparator

placebo

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
No Results Posted