Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

NCT05160532 | Completed Phase 2 FDA Drug

• 1 other identifier: 21-008778
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome.

  Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

Secondary Outcomes (1)

• Change in pain

  Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks

Study Arms (4)

Four injections of placebo

PLACEBO COMPARATOR

Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.

Drug: Placebo

One injection of DPT and three injections of placebo

EXPERIMENTAL

Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.

Drug: Placebo; Drug: Dextrose prolotherapy (DPT)

Two injections of DPT and two injections of placebo

EXPERIMENTAL

Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.

Drug: Placebo; Drug: Dextrose prolotherapy (DPT)

Four injections of DPT

EXPERIMENTAL

Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).

Drug: Dextrose prolotherapy (DPT)

Interventions

Placebo DRUG

5ml of normal saline (NS)

Four injections of placebo; One injection of DPT and three injections of placebo; Two injections of DPT and two injections of placebo

Dextrose prolotherapy (DPT) DRUG

25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.

Four injections of DPT; One injection of DPT and three injections of placebo; Two injections of DPT and two injections of placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
• Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
• Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".

You may not qualify if:

• Pregnancy.
• Diabetes.
• Anticoagulation therapy.
• History of total knee replacement.
• Prior knee prolotherapy or other regenerative product.
• Any knee injection within 3 months.
• Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
• Daily use of opioid medication.
• Allergy or intolerance to study medication, corn allergy.
• Body mass index (BMI) greater than 40 kg/m\^2.
• Comorbidity severe enough to prevent participation in the study protocol.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David Patchett, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: April 10, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)