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

Primary Purpose

Arterial Leg Ulcer

Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Isoniazid 300 milligram
Placebo
Sponsored by
Pharma 2100
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

Placebo tablets.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 31, 2008
Last Updated
March 17, 2021
Sponsor
Pharma 2100
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1. Study Identification

Unique Protocol Identification Number
NCT04802928
Brief Title
Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
Acronym
SONIA
Official Title
Healing of Ischemic Leg Ulcers: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Patients fulfilling the criteria could not be found.
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pharma 2100

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo tablets.
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Isoniazid 300 milligram
Intervention Description
Tablets 150 milligram b.i.d.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The percentage change of ulcer area 8 weeks after initiation of therapy.
Description
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 Outcome Measure Information:
Title
Pain is evaluated by visual analogue scale (VAS).
Description
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
Title
Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)
Description
the number of SUSAR and SAE occurring over the 8-week treatment period is recorded.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonny Karlsmark, MD, PhD
Organizational Affiliation
Bispebjerg Hospital, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark

12. IPD Sharing Statement

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Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

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