Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid

Phase 2

Withdrawn

• Conditions: Arterial Leg Ulcer
• Interventions: Drug: Placebo; Drug: Isoniazid 300 milligram

• Registration Number: NCT04802928
• Lead Sponsor: Pharma 2100

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).

Study Timeline

• Study First Submitted: 2008-03-31
• Study Start: 2008-04
• Primary Completion: 2008-09
• Study Completion: 2008-11
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	Placebo tablets.
B	Isoniazid 300 milligram	-

Primary Outcome Measures

Name	Time	Method
The percentage change of ulcer area 8 weeks after initiation of therapy.	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.

Secondary Outcome Measures

Name	Time	Method
Pain is evaluated by visual analogue scale (VAS).	8 weeks	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)	8 weeks	the number of SUSAR and SAE occurring over the 8-week treatment period is recorded.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark