- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06579638
Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
Study Overview
Status
Conditions
Detailed Description
Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.The prevalence of injected drug use is estimated between 0.09% and 1.3% depending on geographic location. There are various complications of IV drug abuse that are related to the toxicity of the substance, mode of consumption, and drug taking mode. These complications include skin and soft tissue infection (cellulitis, abscess, necrotizing fasciitis) (28%),infected(ranges from .03% to 1%)or non-infected pseudoaneurysm ,arterial ischemia( thrombosis , distal embolization), and venous thrombosis(29%).
The wide spectrum of complications due to IVDA mandates a wide range of treatment for each type starting from simple medical treatment such as antibiotics or anticoagulation to the most extensive surgical treatment options in cases such as PA that may require ligation of the arterial supply without revascularization. This may lead to gravid complications such as limb amputation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Islam M Hassan, Resident
- Phone Number: +2001285007001
- Email: eslammarghny22@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Current IV drug abuser
- (Age from 18 to 80 )
- Presented with peripheral vascular complications (pseudoaneurysm, limb ischemia, venous thrombosis, skin infection.)
Exclusion Criteria:
- Drug intake other than IV
- ( less than 18 or more than 80 )
- Presented with overdose
- Malignancy or serious illness
- Causes of vascular complications other than IV drug abuse
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patterns and outcomes of IVDA
Time Frame: 1 year
|
To describe the patterns, methods of treatment and outcomes of self-injection of addictive drugs such as amputation rate and patency rate.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mostafa S Khalil, Professor, Assiut University
- Study Director: Ashraf G Taha, Assist. prof, Assiut University
- Study Director: Mohamed S Abdelkareem, Lecturer, Assiut University
- Principal Investigator: Islam M Hassan, Resident, Assiut University
Publications and helpful links
General Publications
- Tsao JW, Marder SR, Goldstone J, Bloom AI. Presentation, diagnosis, and management of arterial mycotic pseudoaneurysms in injection drug users. Ann Vasc Surg. 2002 Sep;16(5):652-62. doi: 10.1007/s10016-001-0124-6. Epub 2002 Sep 4.
- Senbanjo R, Strang J. Evaluation of Femoral Ultrasonography as a Tool for Promoting Cessation of Groin-Injecting Behaviour. Eur Addict Res. 2015;21(4):204-10. doi: 10.1159/000375260. Epub 2015 Apr 21.
- Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23. Erratum In: Lancet Glob Health. 2018 Jan;6(1):e36. doi: 10.1016/S2214-109X(17)30446-1.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IVDA Complications
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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