Out-patients with ischemic (arterial) leg ulcers (systolic toe pressure: < 40 mm Hg).
Conditions
Interventions
Trade Name: Isoniazid "Oba"
Product Name: Isoniazid
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: ISONIAZID
CAS Number: 54853
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Pharma 2100 ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years - Patients with ischemic leg ulcers unsutiable for vascular surgical intervention - Systolic toe pressure 3 months - Ulcer area: 1-20 cm2 - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Anaemia (Hb 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, benzodiazepiner (diazepam, triazolam), stavudin and/or valproat - Alcohol abuse - Hereditary galactose intolerance - Hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, polyvidone, 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 |
|---|---|
| Main Objective: To study the effect of oral isoniazid on the percentage change of ulcer area 8 weeks after initiation of therapy.;Secondary Objective: 1. Pain evaluated by visual analogue scale (VAS) 2. Occurrence of unexpected (SUSAR) and serious adverse events (SAE).;Primary end point(s): Wound healing measured as the percentage change of ulcer area 8 weeks after initiation of therapy. | — |
Countries
Denmark
Outcome results
None listed