Genicular Embolization Using Doxycycline Sclerotherapy

NCT07024654 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 25-10650-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective case series is to develop an alternative pain management procedure for patients who are not surgical candidates. The main question it aims to answer is: Is genicular sclerotherapy using doxycycline a safe and effective pain management option for patients with chronic knee pain who are not surgical candidates? OUTCOME MEASURES: Primary: Visual Analog Scale (VAS) score at 3 months Secondary:

• VAS at 12 months
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months

Conditions

Chronic Knee Pain; Osteoarthritis

Keywords

Chronic knee pain; osteoarthritis; genicular sclerotherapy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Primary outcome measure will be visual analog scale scores at 3 months post-op. Scores 0-10, 0 being no pain, 10 being the worst pain.

  3 months post-op

Secondary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  1 year post-op

• Visual Analog Scale (VAS)

  1 year post-op

Study Arms (1)

Doxycycline Genicular Sclerotherapy Arm

EXPERIMENTAL

Participants in this arm will undergo sclerotherapy using doxycycline to target terminal genicular arteries associated with knee pain. The procedure is performed under ultrasound guidance, and the goal is to evaluate the safety and potential efficacy of doxycycline as a sclerosing agent for managing chronic knee pain symptoms.

Drug: Doxycycline Injection

Interventions

Doxycycline Injection DRUG

Injection of doxycycline as a sclerosing agent into the genicular artery region under ultrasound guidance for the purpose of evaluating its effectiveness in reducing knee pain.

Also known as: Ultrasound Guided Sclerotherapy

Doxycycline Genicular Sclerotherapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older.
• KL Score 2-3
• VA Grade \>5
• Native knee
• Willing and able to provide consent.
• Willing and able to complete questionnaires.
• Willing and able to complete follow up visits.
• Speak and write fluent English
• Unilateral knee (if bilateral knee pain, identify knee for procedure)
• All subjects may be included regardless of sex. Women must be either surgically sterilized postmenopausal defined as having no menstrual periods for 12 consecutive months

You may not qualify if:

• Allergies to doxycycline or any other substances used in procedure
• Steroid injection in the index knee within the last 90 days
• Knee surgery on index knee in the last 180 days

Sponsors & Collaborators

• Campbell Clinic: lead

Related Publications (6)

• Bountouroglou DG, Azzam M, Kakkos SK, Pathmarajah M, Young P, Geroulakos G. Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):93-100. doi: 10.1016/j.ejvs.2005.08.024. Epub 2005 Oct 17.

  PMID: 16233981 BACKGROUND

• Wong MN, Murakami JW. Doxycycline Sclerotherapy of Mandibular Aneurysmal Bone Cysts: A Brief Clinical Study. J Craniofac Surg. 2025 Jan-Feb 01;36(1):e31-e33. doi: 10.1097/SCS.0000000000010697. Epub 2024 Sep 23.

  PMID: 39311568 BACKGROUND

• McDermott D, Wakefield D, Kowalsky M, Sethi P, Vitale MA, Morrey BF. Intrabursal Doxycycline Sclerotherapy for Recurrent Olecranon Bursitis of the Elbow: A Case Control Study. J Hand Surg Glob Online. 2024 Apr 8;6(4):504-509. doi: 10.1016/j.jhsg.2024.03.006. eCollection 2024 Jul.

  PMID: 39166200 BACKGROUND

• Liu S, Swilling D, Morris EM, Macaulay W, Golzarian J, Hickey R, Taslakian B. Genicular Artery Embolization: A Review of Essential Anatomic Considerations. J Vasc Interv Radiol. 2024 Apr;35(4):487-496.e6. doi: 10.1016/j.jvir.2023.12.010. Epub 2023 Dec 19.

  PMID: 38128722 BACKGROUND

• Torkian P, Golzarian J, Chalian M, Clayton A, Rahimi-Dehgolan S, Tabibian E, Talaie R. Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jul 14;9(7):23259671211021356. doi: 10.1177/23259671211021356. eCollection 2021 Jul.

  PMID: 34350303 BACKGROUND

• van Zadelhoff TA, Moelker A, Bierma-Zeinstra SMA, Bos PK, Krestin GP, Oei EHG. Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial. Trials. 2022 Jan 8;23(1):24. doi: 10.1186/s13063-021-05942-x.

  PMID: 34998425 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Joshua Brandon, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-group, prospective interventional pilot study

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share