Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
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ClinicalTrials.gov Identifier: NCT00638872 |
Recruitment Status :
Completed
First Posted : March 19, 2008
Last Update Posted : September 11, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Ulcer Foot Ulcer Unhealed | Drug: Polydeoxyribonucleotide Other: 0.9% NaCl | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 215 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing. |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
PDRN
|
Drug: Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections |
Placebo Comparator: placebo
placebo
|
Other: 0.9% NaCl
same as PDRN |
- reduction of ulcer rate [ Time Frame: 3 months ]
- safety and tolerability of the compound [ Time Frame: 6 months ]

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638872
Italy | |
University of Messina | |
Messina, Italy, 98125 |
Study Director: | Giulia Cattarini | Mastelli srl, via Bussana Vecchia, Sanremo, Italy |
Responsible Party: | Francesco Squadrito, Full Professor of Pharmacology, University of Messina |
ClinicalTrials.gov Identifier: | NCT00638872 |
Other Study ID Numbers: |
PLA/01/06 |
First Posted: | March 19, 2008 Key Record Dates |
Last Update Posted: | September 11, 2012 |
Last Verified: | September 2012 |
diabetes foot ulcer polydeoxyribonucleotide |
Foot Ulcer Ulcer Pathologic Processes Foot Diseases |
Skin Diseases Leg Ulcer Skin Ulcer |