Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Arterial Leg Ulcer Clinical Trial

— SONIA  

Official title:

Healing of Ischemic Leg Ulcers: A Pilot Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04802928
• Other study ID #: 2007-003387-22
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2021
• Source: Pharma 2100
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Leg Ulcer
• Leg Ulcer
• Ulcer

Intervention

Drug:
• Isoniazid 300 milligram
Tablets 150 milligram b.i.d.
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Pharma 2100

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 weeks
Secondary	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.	8 weeks