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Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.

NCT ID: NCT06579638

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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IVDA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Islam Marghny Hassan

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa S Khalil, Professor

Role: STUDY_CHAIR

Assiut University

Ashraf G Taha, Assist. prof

Role: STUDY_DIRECTOR

Assiut University

Mohamed S Abdelkareem, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Islam M Hassan, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Islam M Hassan, Resident

Role: CONTACT

Phone: +2001285007001

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 12203000 (View on PubMed)

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.

Reference Type RESULT
PMID: 25896872 (View on PubMed)

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.

Reference Type RESULT
PMID: 29074409 (View on PubMed)

Other Identifiers

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IVDA Complications

Identifier Type: -

Identifier Source: org_study_id