Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Arterial Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Placebo tablets.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

B

Group Type EXPERIMENTAL

Isoniazid 300 milligram

Intervention Type DRUG

Tablets 150 milligram b.i.d.

Interventions

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Isoniazid 300 milligram

Tablets 150 milligram b.i.d.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No