NCT06591741

Brief Summary

Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

September 7, 2024

Last Update Submit

August 18, 2025

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (2)

  • Change in immunity factor CXCL9 from 0 to 3 months

    0 and 3 months

  • Change in HbA1c from 0 to 3 months

    0 and 3 months

Secondary Outcomes (1)

  • Reinfection rate after revision for prosthetic joint infection

    0 to 4 years

Study Arms (1)

PCA administraton

OTHER
Dietary Supplement: Oral PCA

Interventions

Oral PCADIETARY_SUPPLEMENT

PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years

PCA administraton

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • weeks or more after total knee arthroplasty
  • One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
  • WBC count of aspirate \>50,000 cells per μL

You may not qualify if:

  • Not willing to undergo blood draw at 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kenneth D Reeves, M.D.

    K. Dean Reeves, M.D., P.A.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth D Reeves, M.D.

CONTACT

9139637750deanreevesMD@gmail.com

Lanny Johnson, M.D.

CONTACT

5172851812drlannyjohnson@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 19, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 20, 2025

Record last verified: 2025-08