Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

• Status: Withdrawn
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharma 2100
• Treatments: Anti-Bacterial Agents; Isoniazid

Criteria

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