Diabetic UlcerPhase 4NCT00638872
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
A Phase 4 study testing Polydeoxyribonucleotide and 0.9% NaCl in people with Diabetic Ulcer and Foot Ulcer Unhealed, run by University of Messina at 1 site in Italy.
Trial summary
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetic Ulcer, Foot Ulcer Unhealed
- What is being tested?
- Polydeoxyribonucleotide and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Wound free of necrotic debris
- TcPO2 >29mmHg
- Not pregnant or lactant
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.
Read the 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.
- Conditions
- Diabetic Ulcer, Foot Ulcer Unhealed
- Being tested
- Polydeoxyribonucleotide, 0.9% NaCl
- Keywords
- diabetes, foot ulcer, polydeoxyribonucleotide
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydeoxyribonucleotideDrug
3 times a week perilesional or intramuscular injections
0.9% NaClOther
same as PDRN
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PDRN Receives: Drug: Polydeoxyribonucleotide |
| placebo | Placebo comparator | placebo Receives: Other: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of ulcer rate
Measured: 3 months
Secondary outcomes (1)
safety and tolerability of the compound
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Squadrito, University of Messina
- Investigators
- Giulia Cattarini, Study director, Mastelli srl, via Bussana Vecchia, Sanremo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638872
- Sponsor's protocol ID
- PLA/01/06
- Status last verified
- Sep 2012
- First submitted
- 12 Mar 2008
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.
- ClinicalTrials.gov ID
- NCT00638872
- Acronym / sponsor ID
- PLA/01/06
- Conditions
- Diabetic Ulcer, Foot Ulcer Unhealed
- Keywords
- diabetes, foot ulcer, polydeoxyribonucleotide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PolydeoxyribonucleotidePDRN |
| placebo | Placebo comparator | Other: 0.9% NaClplacebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polydeoxyribonucleotide3 times a week perilesional or intramuscular injections | Drug | 1 |
| 0.9% NaClsame as PDRN | Other | placebo |
Primary outcome
reduction of ulcer rate
Time frame: 3 months
1 secondary outcome
safety and tolerability of the compound
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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EDX110 Randomized Control Trial for Treatment of DFUs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Cattarini study director
Mastelli srl, via Bussana Vecchia, Sanremo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polydeoxyribonucleotide and 0.9% NaCl in people with Diabetic Ulcer and Foot Ulcer Unhealed, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of ulcer rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.