Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Pharma 2100

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Arterial Leg Ulcer

Interventions

Isoniazid 300 milligramDRUG

Tablets 150 milligram b.i.d.

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

The percentage change of ulcer area 8 weeks after initiation of therapy.

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.

Time frame: 8 weeks

Secondary Outcomes

Pain is evaluated by visual analogue scale (VAS).

The visual analogue scale ranges from 0 mm (minimum) to 100 mm (maximum), where the lower value the better is the outcome.

Time frame: 8 weeks

Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)

the number of SUSAR and SAE occurring over the 8-week treatment period is recorded.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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