Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
This study has been completed.
Sponsor:
University of Messina
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina
ClinicalTrials.gov Identifier:
NCT00638872
First received: March 12, 2008
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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 Foot Ulcer Unhealed |
Drug: Polydeoxyribonucleotide Other: 0.9% NaCl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing. |
Resource links provided by NLM:
Further study details as provided by University of Messina:
Primary Outcome Measures:
- reduction of ulcer rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety and tolerability of the compound [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 215 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
PDRN
|
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections
|
|
Placebo Comparator: placebo
placebo
|
Other: 0.9% NaCl
same as PDRN
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00638872
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638872
Locations
| Italy | |
| University of Messina | |
| Messina, Italy, 98125 | |
Sponsors and Collaborators
University of Messina
Investigators
| Study Director: | Giulia Cattarini | Mastelli srl, via Bussana Vecchia, Sanremo, Italy |
More Information
| Responsible Party: | Francesco Squadrito, Full Professor of Pharmacology, University of Messina |
| ClinicalTrials.gov Identifier: | NCT00638872 History of Changes |
| Other Study ID Numbers: | PLA/01/06 |
| Study First Received: | March 12, 2008 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by University of Messina:
|
diabetes foot ulcer polydeoxyribonucleotide |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Pathologic Processes Foot Diseases |
Skin Diseases Leg Ulcer Skin Ulcer |
ClinicalTrials.gov processed this record on September 30, 2016