Clinical trial NCT06579638: Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
Official title: Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: IVDA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients developing peripheral vascular complications due to IVDA

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patterns and outcomes of IVDA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa S Khalil, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Ashraf G Taha, Assist. prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed S Abdelkareem, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Islam M Hassan, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.