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Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Primary Purpose

Catocholamine Induced Finger Necrosis

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Botox

Placebo

About this trial

This is an interventional treatment trial for Catocholamine Induced Finger Necrosis focused on measuring Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients treated with vasoactive drugs (amines) and have finger/toe necrosis

Exclusion Criteria:

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

Sites / Locations

Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

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.

Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Outcomes

Primary Outcome Measures

index of Toe and Finger Ischemia (iTFI)

Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Secondary Outcome Measures

Amputation

Amputations performed - fingers, toe and limb - height and number of amputations

Patients survival

Survival

Full Information

NCT ID

NCT01500668

First Posted

December 22, 2011

Last Updated

January 3, 2012

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01500668

Brief Title

Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Official Title

Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catocholamine Induced Finger Necrosis

Keywords

Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Intervention Type

Drug

Intervention Name(s)

Botox

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Primary Outcome Measure Information:

Title

index of Toe and Finger Ischemia (iTFI)

Description

Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Time Frame

three months after drug administration

Secondary Outcome Measure Information:

Title

Amputation

Description

Amputations performed - fingers, toe and limb - height and number of amputations

Time Frame

Three months after drug administration

Title

Patients survival

Description

Survival

Time Frame

Three months after drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients treated with vasoactive drugs (amines) and have finger/toe necrosis Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amir Herman, MD, PhD

Phone

972-52-2655026

amirherm@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Herman, MD, PhD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Tel-Hashomer

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amir Herman, MD, PhD

Phone

972-52-2655026

amirherm@gmail.com

First Name & Middle Initial & Last Name & Degree

Amir Herman, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12771608

Citation

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.

Results Reference

background

PubMed Identifier

19258141

Citation

Fregene 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.

Results Reference

background

PubMed Identifier

7359665

Citation

Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.

Results Reference

background

PubMed Identifier

17255677

Citation

Van 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.

Results Reference

background

PubMed Identifier

21855233

Citation

Janz 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.

Results Reference

background

PubMed Identifier

19116537

Citation

Clemens 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.

Results Reference

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Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

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