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Sponsored by: |
University of Messina |
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Information provided by: | University of Messina |
ClinicalTrials.gov Identifier: | NCT00638872 |
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.
Condition | Intervention | Phase |
---|---|---|
Diabetic Ulcer Vasculopathic Ulcer |
Drug: Polydeoxyribonucleotide Other: 0.9% NaCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing. |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
PDRN
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Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections
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placebo: Placebo Comparator
placebo
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Other: 0.9% NaCl
same as PDRN
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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.
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Domenico Cucinotta, MD | +390902212393 | dcucinotta@unime.it |
Italy | |
University of Messina | Recruiting |
Messina, Italy, 98125 | |
Contact: Domenico Cucinotta, MD +390902212393 dcucinotta@unime.it | |
Principal Investigator: Domenico Cucinotta, MD |
Study Director: | Giulia Cattarini | Mastelli srl, via Bussana Vecchia, Sanremo, Italy |
Responsible Party: | Mastelli srl ( Mastelli srl ) |
Study ID Numbers: | PLA/01/06 |
Study First Received: | March 12, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00638872 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
diabetes foot ulcer polydeoxyribonucleotide |
Foot Ulcer Ulcer Diabetes Mellitus Diabetic Foot |
Pathologic Processes Ulcer |