Chronic Lower Leg Ulcer Clinical Trial
Official title:
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
| NCT number | NCT00658983 |
| Other study ID # | 2008/049 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 1, 2008 |
| Est. completion date | August 20, 2010 |
| Verified date | January 2023 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | August 20, 2010 |
| Est. primary completion date | August 20, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 18 year or older - A non-healing chronic lower leg ulcer - Platelet ranges of 150000 per ml circulating blood Exclusion Criteria: - Presence of a tumor or metastatic disease - Hypersensitive to collagen regenerated cellulose - Hemodynamic unstable patient - Hypercoagulability - Heart decompensation or angina pectoris |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Johnson & Johnson, Medtronic |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wound healing | 6 weeks | ||
| Secondary | Wound healing | 6 months |