Study Stopped
Patients fulfilling the criteria could not be found.
Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
SONIA
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedMarch 19, 2021
March 1, 2021
5 months
March 31, 2008
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (2)
Pain is evaluated by visual analogue scale (VAS).
8 weeks
Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)
8 weeks
Study Arms (2)
A
PLACEBO COMPARATORPlacebo tablets.
B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharma 2100lead
Study Sites (1)
Bispebjerg Hospital
Copenhagen, DK-2400, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Tonny Karlsmark, MD, PhD
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 31, 2008
First Posted
March 17, 2021
Study Start
April 1, 2008
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
March 19, 2021
Record last verified: 2021-03