Chronic Lower Leg UlcerNCT00658983
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
A study testing Autologous Platelet Enriched Gel and Metalloproteinase Inhibitor in people with Chronic Lower Leg Ulcer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lower Leg Ulcer
- What is being tested?
- Autologous Platelet Enriched Gel and Metalloproteinase Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2008to 20 Aug 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year or older
- A non-healing chronic lower leg ulcer
- Platelet ranges of 150000 per ml circulating blood
Who cannot join
- Presence of a tumor or metastatic disease
- Hypersensitive to collagen regenerated cellulose
- Hemodynamic unstable patient
- Hypercoagulability
- Heart decompensation or angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.
- Conditions
- Chronic Lower Leg Ulcer
- Being tested
- Autologous Platelet Enriched Gel, Metalloproteinase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Enriched GelOther
Treatment with Autologous Platelet Enriched Gel
Metalloproteinase InhibitorOther
Treatment with Metalloproteinase Inhibitor (Promogran)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Autologous Platelet Enriched Gel Receives: Other: Autologous Platelet Enriched Gel |
| 2 | Active comparator | Metalloproteinase Inhibitor (Promogran) Receives: Other: Metalloproteinase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: 6 weeks
Secondary outcomes (1)
Wound healing
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 posted16 Apr 2008 (estimated)
- Study start1 Apr 2008
- Primary completion20 Aug 2010
- Study completion20 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Leg UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Wim Bongaerts, MD, Principal investigator, University Hospital, GhentWouter De Moor, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658983
- Sponsor's protocol ID
- 2008/049
- Status last verified
- Jan 2023
- First submitted
- 7 Apr 2008
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
- ClinicalTrials.gov ID
- NCT00658983
- Acronym / sponsor ID
- 2008/049
- Conditions
- Chronic Lower Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic, Johnson & Johnson
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 20 Aug 2010 (actual)
- Study completion
- 20 Aug 2010 (actual)
- First posted
- 16 Apr 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.
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Autologous Platelet Enriched GelAutologous Platelet Enriched Gel |
| 2 | Active comparator | Other: Metalloproteinase InhibitorMetalloproteinase Inhibitor (Promogran) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 year or older
- A non-healing chronic lower leg ulcer
- Platelet ranges of 150000 per ml circulating blood
Key exclusion criteria (5 listed)
- Presence of a tumor or metastatic disease
- Hypersensitive to collagen regenerated cellulose
- Hemodynamic unstable patient
- Hypercoagulability
- Heart decompensation or angina pectoris
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 |
|---|---|---|
| Autologous Platelet Enriched GelTreatment with Autologous Platelet Enriched Gel | Other | 1 |
| Metalloproteinase InhibitorTreatment with Metalloproteinase Inhibitor (Promogran) | Other | 2 |
Primary outcome
Wound healing
Time frame: 6 weeks
1 secondary outcome
Wound healing
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 5 Jan 2023.
- Related InfoLink provided by the sponsor.
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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.
Wim Bongaerts, MD principal investigator
University Hospital, Ghent
Wouter De Moor principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet Enriched Gel and Metalloproteinase Inhibitor in people with Chronic Lower Leg Ulcer, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 5 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 5 Jan 2023. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Wound healing (time frame: 6 weeks). 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 5 Jan 2023.