Knee OsteoarthritisPhase 2NCT05160532
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
A Phase 2 study testing Dextrose prolotherapy (DPT) in people with Knee Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Dextrose prolotherapy (DPT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2022to 31 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?".
Who cannot join
- Pregnancy.
- Diabetes.
- Anticoagulation therapy.
- History of total knee replacement.
- Prior knee prolotherapy or other regenerative product.
- Any knee injection within 3 months.
Show all 13Show fewer
- 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.
- Use of oral steroids during the study period
- Use of injectable steroids in the past 3 months or during the study period
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Placebo, Dextrose prolotherapy (DPT)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
5ml of normal saline (NS)
Dextrose prolotherapy (DPT)Drug
25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Drug: Dextrose prolotherapy (DPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
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 0-96, with higher scores indicating worse outcome.
Measured: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52
Secondary outcomes (4)
Change in Pain
Measured using a visual analogue scale with 0 = no pain and 10=worst pain with higher scores indicating worse pain.
Measured: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function in individuals with knee OA. Total scores range from 0-68, with higher scores indicating worse physical function.
Measured: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure stiffness in individuals with knee OA. Total scores range from 0-8, with higher scores indicating worse stiffness.
Measured: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure pain in individuals with knee OA. Total scores range from 0-20, with higher scores indicating worse pain.
Measured: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start10 Apr 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Patchett, DO, Mayo Clinic
- Investigators
- David Patchett, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160532
- Sponsor's protocol ID
- 21-008778
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2021
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05160532
- Acronym / sponsor ID
- 21-008778
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Four injections of placebo | Placebo comparator | Drug: PlaceboSubjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient. |
| One injection of DPT and three injections of placebo | Experimental | Drug: Placebo, Drug: Dextrose prolotherapy (DPT)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. |
| Two injections of DPT and two injections of placebo | Experimental | Drug: Placebo, Drug: Dextrose prolotherapy (DPT)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. |
| Four injections of DPT | Experimental | Drug: Dextrose prolotherapy (DPT)Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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?".
Key exclusion criteria (13 listed)
- Pregnancy.
- Diabetes.
- Anticoagulation therapy.
- History of total knee replacement.
- Prior knee prolotherapy or other regenerative product.
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 |
|---|---|---|
| Placebo5ml of normal saline (NS) | Drug | 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)25% dextrose, mixing 2.5ml of sterile water and 2.5ml of 50% dextrose. | Drug | Four injections of DPT, One injection of DPT and three injections of placebo, Two injections of DPT and two injections of placebo |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52
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 0-96, with higher scores indicating worse outcome.
4 secondary outcomes
Change in Pain
Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Time frame: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
David Patchett, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextrose prolotherapy (DPT) in people with Knee Osteoarthritis, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score (time frame: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.