Chronic Knee PainPhase 2NCT07024654
Genicular Embolization Using Doxycycline Sclerotherapy
A Phase 2 study testing Doxycycline Injection in people with Chronic Knee Pain and Osteoarthritis, run by Campbell Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain, Osteoarthritis
- What is being tested?
- Doxycycline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
About this study
Official title: A Prospective Case Series: Genicular Embolization Using Doxycycline Sclerotherapy
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
Read the detailed description
The purpose of this study is to develop an alternative pain management procedure for patients who are not surgical candidates. Using sclerotherapy (a procedure in which a medication is injected into small blood vessels causing them to scar, shrink and collapse) in the small terminal branches of some of the blood vessels in the knee, the aim is to adapt this proven therapy for varicose veins, cysts, and vascular malformations to pain management. Doxycycline will be used as the injectable to perform the procedure. Doxycyline is a FDA approved medication commonly used for bacterial infections and is is frequently used off-label as a sclerosing agent; however, it is not specifically FDA approved for use in sclerotherapy.
This is a pilot study. A pilot study is a small-scale, preliminary study conducted before a larger, more comprehensive research project. Its purpose is to test and refine the research methods, procedures, and instruments, ensuring they are feasible, practical, and reliable.
Visit 1: Consent and treatment procedure: Subjects will be consented and baseline VAS (visual analog scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)will be obtained. Procedure will be performed by one of the study providers as follows: Following sterile cleaning of the skin and administration of lidocaine to anesthetize injection tract, ultrasound guidance will be utilized to isolate target sites of the peripheral vasculature of the genicular artery in one knee. Up to four sites in the index knee may be injected as needed based on pain presentation and physician's discretion. A maximum of 100 milligrams of doxycycline diluted in 10 milliliters of sterile water will be used per subject. Post procedure icing will be performed for 15 minutes to help prevent the occurrence of ischemia and bruising.
Post-operatively, a prescription for either Lortab or Tramadol will be offered and an over the counter pain medication option will be recommended.
If the subject experiences an adverse event, please contact the study provider for an exam, lab-work and/or consultation as needed.
Following the procedure, restrict activity for 1-2 weeks to protected weight bearing and to advance as tolerated.
Visit 2: 2 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 3: 6 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 4: 3 months post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 5: 6 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 6: 9 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 7: 12 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
- Conditions
- Chronic Knee Pain, Osteoarthritis
- Being tested
- Doxycycline Injection
- Keywords
- Chronic knee pain, osteoarthritis, genicular sclerotherapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline InjectionDrug
Also called Ultrasound Guided Sclerotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Doxycycline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-op
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Secondary outcome measure will be Western Ontario and McMaster Universities Osteoarthritis Index scores at 1 year.
Scores scale from 0 (no symptoms) to 96 (maximum pain, stiffness, and physical dysfunction)
Measured: 1 year post-op
Visual Analog Scale (VAS)
Secondary outcome measure will be visual analog scale scores at 1 year post-op. Scores 0-10, 0 being no pain, 10 being the worst pain.
Measured: 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Why it stopped: unable to obtain IND approval from FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-group, prospective interventional pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Brandon, Campbell Clinic
- Investigators
- Joshua Brandon, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024654
- Sponsor's protocol ID
- 25-10650-FB
- Status last verified
- Feb 2026
- First submitted
- 9 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16233981Wong 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.
PubMed 39311568McDermott 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.
PubMed 39166200Liu 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.
PubMed 38128722Torkian 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.
PubMed 34350303van 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.
PubMed 34998425
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series: Genicular Embolization Using Doxycycline Sclerotherapy
- ClinicalTrials.gov ID
- NCT07024654
- Acronym / sponsor ID
- 25-10650-FB
- Conditions
- Chronic Knee Pain, Osteoarthritis
- Keywords
- Chronic knee pain, osteoarthritis, genicular sclerotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to obtain IND approval from FDA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The purpose of this study is to develop an alternative pain management procedure for patients who are not surgical candidates. Using sclerotherapy (a procedure in which a medication is injected into small blood vessels causing them to scar, shrink and collapse) in the small terminal branches of some of the blood vessels in the knee, the aim is to adapt this proven therapy for varicose veins, cysts, and vascular malformations to pain management. Doxycycline will be used as the injectable to perform the procedure. Doxycyline is a FDA approved medication commonly used for bacterial infections and is is frequently used off-label as a sclerosing agent; however, it is not specifically FDA approved for use in sclerotherapy.
This is a pilot study. A pilot study is a small-scale, preliminary study conducted before a larger, more comprehensive research project. Its purpose is to test and refine the research methods, procedures, and instruments, ensuring they are feasible, practical, and reliable.
Visit 1: Consent and treatment procedure: Subjects will be consented and baseline VAS (visual analog scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)will be obtained. Procedure will be performed by one of the study providers as follows: Following sterile cleaning of the skin and administration of lidocaine to anesthetize injection tract, ultrasound guidance will be utilized to isolate target sites of the peripheral vasculature of the genicular artery in one knee. Up to four sites in the index knee may be injected as needed based on pain presentation and physician's discretion. A maximum of 100 milligrams of doxycycline diluted in 10 milliliters of sterile water will be used per subject. Post procedure icing will be performed for 15 minutes to help prevent the occurrence of ischemia and bruising.
Post-operatively, a prescription for either Lortab or Tramadol will be offered and an over the counter pain medication option will be recommended.
If the subject experiences an adverse event, please contact the study provider for an exam, lab-work and/or consultation as needed.
Following the procedure, restrict activity for 1-2 weeks to protected weight bearing and to advance as tolerated.
Visit 2: 2 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 3: 6 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 4: 3 months post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 5: 6 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 6: 9 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Visit 7: 12 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-group, prospective interventional pilot study
| Arm | Type | Receives |
|---|---|---|
| Doxycycline Genicular Sclerotherapy Arm | Experimental | Drug: Doxycycline InjectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age or older.
- KL Score 2-3
- VA Grade >5
- Native knee
- Willing and able to provide consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline InjectionAlso: Ultrasound Guided SclerotherapyInjection 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. | Drug | Doxycycline Genicular Sclerotherapy Arm |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 3 months post-op
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.
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 1 year post-op
Visual Analog Scale (VAS)
Time frame: 1 year post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 16233981Bountouroglou 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.
- Background: PubMed 39311568Wong 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.
- Background: PubMed 39166200McDermott 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.
- Background: PubMed 38128722Liu 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.
- Background: PubMed 34350303Torkian 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.
- Background: PubMed 34998425van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Brandon, MD principal investigator
Campbell Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline Injection in people with Chronic Knee Pain and Osteoarthritis, run by Campbell Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024654, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.