Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Healing of Ischemic Leg Ulcers: A Pilot Trial

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).

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