Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid (SONIA)

March 17, 2021 updated by: Magnus Agren, Pharma 2100

Healing of Ischemic Leg Ulcers: A Pilot Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Drug: Isoniazid 300 milligram
Tablets 150 milligram b.i.d.
Placebo Comparator: A
Placebo tablets.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage change of ulcer area 8 weeks after initiation of therapy.
Time Frame: 8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain is evaluated by visual analogue scale (VAS).
Time Frame: 8 weeks
The visual analogue scale ranges from 0 mm (minimum) to 100 mm (maximum), where the lower value the better is the outcome.
8 weeks
Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)
Time Frame: 8 weeks
the number of SUSAR and SAE occurring over the 8-week treatment period is recorded.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharma 2100

Investigators

  • Principal Investigator: Tonny Karlsmark, MD, PhD, Bispebjerg Hospital, Copenhagen, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

September 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003387-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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