Arterial Leg UlcerPhase 2SONIANCT04802928
Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
A Phase 2 study testing Isoniazid 300 milligram in people with Arterial Leg Ulcer, run by Pharma 2100 at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Leg Ulcer
- What is being tested?
- Isoniazid 300 milligram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing of Ischemic Leg Ulcers: A Pilot Trial
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.
Read the 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).
- Conditions
- Arterial Leg Ulcer
- Being tested
- Isoniazid 300 milligram, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid 300 milligramDrug
Tablets 150 milligram b.i.d.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo tablets. Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Isoniazid 300 milligram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startApr 2008
- Primary completionSep 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: Patients fulfilling the criteria could not be found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma 2100
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Magnus Agren, Pharma 2100
- Investigators
- Tonny Karlsmark, MD, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802928
- Sponsor's protocol ID
- 2007-003387-22
- Acronym
- SONIA
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2008
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Ischemic Leg Ulcers: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04802928
- Acronym / sponsor ID
- SONIA / 2007-003387-22
- Conditions
- Arterial Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients fulfilling the criteria could not be found.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pharma 2100Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo tablets. |
| B | Experimental | Drug: Isoniazid 300 milligram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoniazid 300 milligramTablets 150 milligram b.i.d. | Drug | B |
| PlaceboPlacebo | Drug | A |
Primary outcome
The percentage change of ulcer area 8 weeks after initiation of therapy.
Time frame: 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.
2 secondary outcomes
Pain is evaluated by visual analogue scale (VAS).
Time frame: 8 weeks
Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonny Karlsmark, MD, PhD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoniazid 300 milligram in people with Arterial Leg Ulcer, run by Pharma 2100 at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change of ulcer area 8 weeks after initiation of therapy. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.