Status:
WITHDRAWN
Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
Lead Sponsor:
Pharma 2100
Conditions:
Arterial Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04802928
Start Date
April 1 2008
End Date
November 1 2008
Last Update
March 19 2021
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen, Denmark, DK-2400