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 |
| 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.
For general information, see Learn About Clinical Studies.
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
Additional Information:
No publications provided
| 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:
|
Foot Ulcer Ulcer Foot Diseases Leg Ulcer |
Pathologic Processes Skin Diseases Skin Ulcer |
ClinicalTrials.gov processed this record on March 03, 2015