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Patients fulfilling the criteria could not be found.
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The main objective of this trial is to study the healing effect of an oral drug (isoniazid) in patients with ischemic (arterial) leg ulcers defined by a systolic toe pressure <40 mm Hg.
Treatment of arterial ulcers is problematic. Previous pharmaceutical interventions with for example prostaglandins have produced only limited beneficial effects but have been associated with frequent adverse effects. Positive effects of isoniazid have been observed in a preclinical model of ischemic wound healing (Weinreich et al. Surgery 2010).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo tablets. |
|
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazid 300 milligram | Drug | Tablets 150 milligram b.i.d. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change of ulcer area 8 weeks after initiation of therapy. | The wound area is measured at week 0 (A0) and at 8 weeks (A8). From these measurements, the percentage (%) change of the wound area in relation to the start time (week 0) is determined from the following formula: (A0-A8)/A0*100. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain is evaluated by visual analogue scale (VAS). | The visual analogue scale ranges from 0 mm (minimum) to 100 mm (maximum), where the lower value the better is the outcome. | 8 weeks |
| Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, MD, PhD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | DK-2400 | Denmark |
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| Drug |
Placebo |
|
the number of SUSAR and SAE occurring over the 8-week treatment period is recorded. |
| 8 weeks |