Status:
COMPLETED
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
Lead Sponsor:
University of Messina
Conditions:
Diabetic Ulcer
Foot Ulcer Unhealed
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
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 receiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00638872
Start Date
October 1 2007
End Date
December 1 2011
Last Update
September 11 2012
Active Locations (1)
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1
University of Messina
Messina, Italy, 98125