Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Pharma 2100

Status and phase

Withdrawn

Phase 2

Conditions

Arterial Leg Ulcer

Treatments

Drug: Placebo

Drug: Isoniazid 300 milligram

Study type

Interventional

Funder types

Industry

Identifiers

NCT04802928

2007-003387-22

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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