Catocholamine Induced Finger NecrosisPhase 4NCT01500668
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
A Phase 4 study testing Botox in people with Catocholamine Induced Finger Necrosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catocholamine Induced Finger Necrosis
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 4
- 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 treated with vasoactive drugs (amines) and have finger/toe necrosis
Who cannot join
- Sensitivity to drug (Botox) ingredients.
- Active local limb infection
- ICU admission due to botulism
- Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS
- Age lower than 18
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
Amir Herman, MD, PhD, 972-52-2655026, amirherm@gmail.com
Amir Herman, MD, PhD
About this study
Official title: Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.
- Conditions
- Catocholamine Induced Finger Necrosis
- Being tested
- Botox, Placebo
- Keywords
- Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin
- Medical subject headings
- Shock, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.
PlaceboDrug
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries. Receives: Drug: Botox |
| Control | Placebo comparator | Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
index of Toe and Finger Ischemia (iTFI)
Score including:
O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration
Measured: three months after drug administration
Secondary outcomes (2)
Amputation
Amputations performed - fingers, toe and limb - height and number of amputations
Measured: Three months after drug administration
Patients survival
Survival
Measured: Three months after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Catocholamine Induced Finger NecrosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Amir Herman, Sheba Medical Center
- Investigators
- Amir Herman, MD, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500668
- Sponsor's protocol ID
- SHEBA-11-9023-AH-CTIL
- Other IDs
- 9023-11-SMC
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunser MW, Mayr AJ, Tur A, Pajk W, Barbara F, Knotzer H, Ulmer H, Hasibeder WR. Ischemic skin lesions as a complication of continuous vasopressin infusion in catecholamine-resistant vasodilatory shock: incidence and risk factors. Crit Care Med. 2003 May;31(5):1394-8. doi: 10.1097/01.CCM.0000059722.94182.79.
PubMed 12771608Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 2009 Mar;34(3):446-52. doi: 10.1016/j.jhsa.2008.11.026.
PubMed 19258141Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.
PubMed 7359665Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-226. doi: 10.1097/01.prs.0000244860.00674.57.
PubMed 17255677Janz BA, Thomas PR, Fanua SP, Dunn RE, Wilgis EF, Means KR Jr. Prevention of anastomotic thrombosis by botulinum toxin B after acute injury in a rat model. J Hand Surg Am. 2011 Oct;36(10):1585-91. doi: 10.1016/j.jhsa.2011.07.008. Epub 2011 Aug 19.
PubMed 21855233Clemens MW, Higgins JP, Wilgis EFS. Prevention of anastomotic thrombosis by botulinum toxin a in an animal model. Plast Reconstr Surg. 2009 Jan;123(1):64-70. doi: 10.1097/PRS.0b013e3181904c31.
PubMed 19116537
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
- ClinicalTrials.gov ID
- NCT01500668
- Acronym / sponsor ID
- SHEBA-11-9023-AH-CTIL
- Conditions
- Catocholamine Induced Finger Necrosis
- Keywords
- Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Dec 2011 (estimated)
- 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.
Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: BotoxInjection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries. |
| Control | Placebo comparator | Drug: PlaceboInjection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated with vasoactive drugs (amines) and have finger/toe necrosis
Key exclusion criteria (5 listed)
- Sensitivity to drug (Botox) ingredients.
- Active local limb infection
- ICU admission due to botulism
- Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS
- Age lower than 18
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 |
|---|---|---|
| BotoxInjection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries. | Drug | Treatment |
| PlaceboInjection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm. | Drug | Control |
Primary outcome
index of Toe and Finger Ischemia (iTFI)
Time frame: three months after drug administration
Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration
2 secondary outcomes
Amputation
Time frame: Three months after drug administration
Patients survival
Time frame: Three months after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Background: PubMed 12771608Dunser MW, Mayr AJ, Tur A, Pajk W, Barbara F, Knotzer H, Ulmer H, Hasibeder WR. Ischemic skin lesions as a complication of continuous vasopressin infusion in catecholamine-resistant vasodilatory shock: incidence and risk factors. Crit Care Med. 2003 May;31(5):1394-8. doi: 10.1097/01.CCM.0000059722.94182.79.
- Background: PubMed 19258141Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 2009 Mar;34(3):446-52. doi: 10.1016/j.jhsa.2008.11.026.
- Background: PubMed 7359665Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.
- Background: PubMed 17255677Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-226. doi: 10.1097/01.prs.0000244860.00674.57.
- Background: PubMed 21855233Janz BA, Thomas PR, Fanua SP, Dunn RE, Wilgis EF, Means KR Jr. Prevention of anastomotic thrombosis by botulinum toxin B after acute injury in a rat model. J Hand Surg Am. 2011 Oct;36(10):1585-91. doi: 10.1016/j.jhsa.2011.07.008. Epub 2011 Aug 19.
- Background: PubMed 19116537Clemens MW, Higgins JP, Wilgis EFS. Prevention of anastomotic thrombosis by botulinum toxin a in an animal model. Plast Reconstr Surg. 2009 Jan;123(1):64-70. doi: 10.1097/PRS.0b013e3181904c31.
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.
Amir Herman, MD, PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox in people with Catocholamine Induced Finger Necrosis, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2012. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Herman, MD, PhD (972-52-2655026, amirherm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
index of Toe and Finger Ischemia (iTFI) (time frame: three months after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500668, which also lists 6 linked publications.
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 5 Jan 2012.