Arterial Leg Ulcer
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGIsoniazid 300 milligram
Tablets 150 milligram b.i.d.
DRUGPlacebo
Placebo
Sponsors
Pharma 2100
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with ischemic leg ulcers unsuitable for vascular surgical intervention * Systolic toe pressure \< 40 mm Hg * Ulcer duration \> 3 months * Ulcer area: 1-20 cm2 * Written informed consent
Exclusion criteria
* B-Hb \< 6 mmol/l * Aspartate transaminase \> 50 U/l * Diabetes mellitus \> 10%HbA1c * Usage of more than 10 mg prednisolone daily within the last 30 days * Usage of cytotoxic agents with the last 3 months * Usage of rifampicin, phenytoin, carbamazepin, theophylline, benzodiazepines (diazepam, triazolam), stavudine and/or valproat * Alcohol abuse * Hereditary galactose intolerance * Hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, povidone, talcum, lactose and starch) * Cellulitis or deep infection (osteomyelitis and/or tendonitis) related to the ulcer * Gangrene * Participation in clinical trials within the last 7 days * Pregnancy or breastfeeding * Women of child bearing potential who decline to use contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage change of ulcer area 8 weeks after initiation of therapy. | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain is evaluated by visual analogue scale (VAS). | 8 weeks | The visual analogue scale ranges from 0 mm (minimum) to 100 mm (maximum), where the lower value the better is the outcome. |
| Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE) | 8 weeks | the number of SUSAR and SAE occurring over the 8-week treatment period is recorded. |
Countries
Denmark
Outcome results
None listed