Arthritis AnklePhase 2/3NCT06907121
Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
A Phase 2/3 study testing Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma in people with Arthritis Ankle and Arthritis Knee, run by Integrant Pty Ltd at 1 site in Australia.
Trial summary
This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle osteoarthritis. The study, sponsored by Integrant Pty Ltd and Prof. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis Ankle, Arthritis Knee
- What is being tested?
- Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle/Knee arthritis resistant to treatment in GP clinic setting.
- Radiographically confirmed cartilage injury with Kellgren-Lawrence grade 1-3 can be shown on MRI scan or weight bearing X-Ray within 6 months of study application.
- Able to give informed consent to participate in a clinical trial.
- Able to commit to attending a clinic for follow up.
Who cannot join
- Known contraindications for ARTG registered somatropin from various manufacturers (Humatrope, Genotropin) have been used to guide the development of somatropin-related exclusion criteria.
- A known hypersensitivity to any of the components of the product.
- Cancer diagnosis or suspicion.
- Resected or active tumour.
- Skeletally immature (<18 years of age or no radiographic evidence of closure of epiphyses).
- Pregnancy/breastfeeding (participants of childbearing potential need negative pregnancy test in prior screening and agreed upon method of contraception throughout duration of study)
Show all 15Show fewer
- Active infection at the injection site.
- Open soft tissue injury.
- Metabolic disorders known to adversely affect the skeleton (e.g. renal osteodystrophy or hypercalcemia), other than primary osteoporosis or diabetes.
- Over 70 years of age.
- Unstable joint or maligned joint > 5 degrees.
- Severe osteoarthritis (Kellgren-Lawrence grade 4 on baseline imaging), including bone-on-bone joints with no detectable cartilage.
- Known hypersensitivity to citrate or somatropin.
- Unable to give informed consent.
- Unable to commit to attend clinic for all follow ups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Integrant Office
Potts Point, New South Wales, 2011
Zadane F Bachmid, +61 7232 1156, zadane@integrant.com.au
Joseph Gracé, Doctor
About this study
Official title: A Double-Blind Randomised, Saline-Controlled Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults With Knee and Ankle Arthritis Resistant to Treatment.
This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle osteoarthritis.
The study, sponsored by Integrant Pty Ltd and Prof. Reza Salleh as the primary investigator, is a Phase IIb, double-blind, randomised, placebo-controlled trial designed to determine whether IA rhGH and PRP can improve joint function and symptoms compared with saline placebo.
Read more
The study will recruit 192 participants, with separate knee and ankle cohorts. Participants will receive five IA injections, administered 7-16 days apart. The active treatment consists of 15 IU somatropin combined with 10 mL PRP per injection, while the control group will receive volume-matched sterile saline.
Outcomes will be assessed using WOMAC for knee participants and FAOS for ankle participants, with the primary endpoint assessed at 6 months after the final injection. Treatment success is defined as a ≥30% improvement from baseline in the relevant joint-specific score.
The study hypothesises that intra-articular rhGH combined with PRP will improve pain, symptoms and physical function in patients with treatment-resistant arthritis compared with saline placebo, potentially providing a non-surgical treatment option for these patients.
Read the detailed description
This clinical study will evaluate the efficacy and safety of intra-articular (IA) administration of recombinant human growth hormone (rhGH; somatropin) in combination with platelet-rich plasma (PRP) in adults with knee and ankle osteoarthritis resistant to conventional treatment. The investigational product will consist of 15 IU of somatropin combined with 10 mL of autologous PRP per injection.
The study, sponsored by Integrant Pty Ltd, will be conducted as a Phase IIb, multi-centre, double-blind, randomised, placebo-controlled, parallel-group superiority trial. Participants will be randomised 1:1 to receive either rhGH + PRP or volume-matched saline placebo. The primary site is St John of God Subiaco, with RegenU Clinics in Potts Point as the secondary site.
The study will recruit 192 participants, comprising 96 participants in the knee cohort and 96 participants in the ankle cohort. Within each cohort, 48 participants will receive rhGH + PRP and 48 will receive saline placebo. Participants will receive five IA injections into the affected knee or ankle joint, administered 7-16 days apart, over approximately 4-9 weeks. Injections will be performed under ultrasound guidance. Following each injection, participants in both treatment groups will undergo 20 minutes of non-invasive joint distraction.
Participants randomised to the placebo group will receive sterile normal saline (0.9% NaCl), volume-matched at approximately 10-12 mL per injection. To maintain the double-blind design, blood will also be collected from placebo participants for PRP preparation, but the blood will be discarded and the participant will receive saline only. Active and placebo preparations will be administered using identical opaque syringes and study-code labelling, with preparation performed by an independent unblinded clinical staff member. Participants, treating clinicians and outcome assessors will remain blinded to treatment allocation.
The inclusion criteria include ankle or knee arthritis resistant to treatment in the GP clinic setting; radiographically confirmed cartilage injury with Kellgren-Lawrence grade 0-3 demonstrated on MRI or weight-bearing X-ray within six months of study application; ability to provide informed consent; and ability to attend required follow-up visits. Exclusion criteria include known hypersensitivity to any component of the product; cancer diagnosis or suspicion; active or resected tumour; skeletal immaturity; pregnancy or breastfeeding; active infection at the injection site; open soft-tissue injury; specified metabolic disorders affecting the skeleton; age over 70 years; unstable or malaligned joint greater than 5 degrees; severe osteoarthritis classified as Kellgren-Lawrence grade 4, including bone-on-bone joints with no detectable cartilage; hypersensitivity to citrate or somatropin; inability to provide informed consent; or inability to attend required follow-up visits.
The primary endpoint is the proportion of participants achieving treatment success at six months, defined as a ≥30% improvement from baseline in the joint-specific functional score compared with the control group. FAOS will be used for participants with ankle osteoarthritis and WOMAC for participants with knee osteoarthritis. Secondary assessments include clinical assessment of symptoms and function at three months and six months, as well as repeat MRI and X-ray imaging at six months.
Blood samples will be collected for HGH measurement, including samples taken before and two hours after each injection following the baseline assessment. These measurements will be used to assess systemic exposure and the local versus systemic pharmacodynamic effects of the intervention. Safety will also be monitored through adverse-event assessment, laboratory testing and ongoing independent medical review.
The study hypothesises that intra-articular rhGH combined with PRP, administered within the standardised joint-distraction protocol, will improve clinical outcomes in patients with treatment-resistant knee or ankle osteoarthritis compared with saline placebo. The study is intended to provide preliminary evidence of efficacy and safety and inform the design of a subsequent Phase III clinical trial.
- Conditions
- Arthritis Ankle, Arthritis Knee
- Being tested
- Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma, Saline (NaCl 0,9 %) (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Articular Injection of Growth Hormone and Platelet-Rich PlasmaDrug
Intervention will be an intra-articular injection of 15 units of HGH and 10 mL PRP conjunct. Five total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Saline (NaCl 0,9 %) (placebo)Drug
To enable a double-blind 1:1 randomised controlled design, the control arm will receive intra-articular sterile saline (0.9% sodium chloride) as placebo. Normal saline is the standard placebo used in many intra-articular injection trials for osteoarthritis. It can be easily matched for volume (~10-12 mL) and appearance (using identical opaque syringes and study codes) to maintain effective blinding for participants, injecting physicians, and outcome assessors.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Ankle Arthritis | Active comparator | Injection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. Receives: Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma |
| Treatment of Knee Arthritis | Active comparator | Injection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. Receives: Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma |
| Placebo Saline Control Arm for Knee | Placebo comparator | Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
| Placebo Saline Control Arm for Ankle | Placebo comparator | Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle mobility and functionality test with FAOS scale
The Foot and Ankle Outcome Score (FAOS) scale is a widely used outcome measure for ankle and hindfoot conditions, including ankle arthritis, assessing pain, function, and alignment, with scores ranging from 0 to 100, where higher scores indicate better function.
Measured: Baseline, 6-months after final injection
Knee mobility and functionality test with WOMAC scale
The Western Ontario and McMaster Universities Arthritic Index (WOMAC) is a validated self-administered health status measure used in assessing pain, stiffness, and function in patients with arthritic knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation, with the score range being 0-68. A higher score indicates worse symptons.
Measured: Baseline, 6-months after final injection
Secondary outcomes (2)
MRI Imaging of the affected arthritic joint
The MRI scans will be evaluated by a radiologist blinded to the treatment allocation to assess changes in: Cartilage volume and thickness, Synovial inflammation (e.g., synovitis), Bone marrow edema, Osteophyte formation, Other structural changes relevant to arthritis progression
Measured: Baseline, 6-months after final injection
Blood test for hormone
Blood tests to check for growth hormone within the blood system.
Measured: Baseline, 2 hours after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis AnkleStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 4 arms of the study. One active treatment for ankle injections, one active treatment for knee injections, one saline placebo control group for ankle injections and one saline placebo control group for knee injections.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrant Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reza Salleh, Associate Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907121
- Sponsor's protocol ID
- INT-2025-02-12
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomised, Saline-Controlled Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults With Knee and Ankle Arthritis Resistant to Treatment.
- ClinicalTrials.gov ID
- NCT06907121
- Acronym / sponsor ID
- INT-2025-02-12
- Conditions
- Arthritis Ankle, Arthritis Knee
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Integrant Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 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.
This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle osteoarthritis.
The study, sponsored by Integrant Pty Ltd and Prof. Reza Salleh as the primary investigator, is a Phase IIb, double-blind, randomised, placebo-controlled trial designed to determine whether IA rhGH and PRP can improve joint function and symptoms compared with saline placebo.
The study will recruit 192 participants, with separate knee and ankle cohorts. Participants will receive five IA injections, administered 7-16 days apart. The active treatment consists of 15 IU somatropin combined with 10 mL PRP per injection, while the control group will receive volume-matched sterile saline.
Outcomes will be assessed using WOMAC for knee participants and FAOS for ankle participants, with the primary endpoint assessed at 6 months after the final injection. Treatment success is defined as a ≥30% improvement from baseline in the relevant joint-specific score.
The study hypothesises that intra-articular rhGH combined with PRP will improve pain, symptoms and physical function in patients with treatment-resistant arthritis compared with saline placebo, potentially providing a non-surgical treatment option for these patients.
Detailed description
This clinical study will evaluate the efficacy and safety of intra-articular (IA) administration of recombinant human growth hormone (rhGH; somatropin) in combination with platelet-rich plasma (PRP) in adults with knee and ankle osteoarthritis resistant to conventional treatment. The investigational product will consist of 15 IU of somatropin combined with 10 mL of autologous PRP per injection.
The study, sponsored by Integrant Pty Ltd, will be conducted as a Phase IIb, multi-centre, double-blind, randomised, placebo-controlled, parallel-group superiority trial. Participants will be randomised 1:1 to receive either rhGH + PRP or volume-matched saline placebo. The primary site is St John of God Subiaco, with RegenU Clinics in Potts Point as the secondary site.
The study will recruit 192 participants, comprising 96 participants in the knee cohort and 96 participants in the ankle cohort. Within each cohort, 48 participants will receive rhGH + PRP and 48 will receive saline placebo. Participants will receive five IA injections into the affected knee or ankle joint, administered 7-16 days apart, over approximately 4-9 weeks. Injections will be performed under ultrasound guidance. Following each injection, participants in both treatment groups will undergo 20 minutes of non-invasive joint distraction.
Participants randomised to the placebo group will receive sterile normal saline (0.9% NaCl), volume-matched at approximately 10-12 mL per injection. To maintain the double-blind design, blood will also be collected from placebo participants for PRP preparation, but the blood will be discarded and the participant will receive saline only. Active and placebo preparations will be administered using identical opaque syringes and study-code labelling, with preparation performed by an independent unblinded clinical staff member. Participants, treating clinicians and outcome assessors will remain blinded to treatment allocation.
The inclusion criteria include ankle or knee arthritis resistant to treatment in the GP clinic setting; radiographically confirmed cartilage injury with Kellgren-Lawrence grade 0-3 demonstrated on MRI or weight-bearing X-ray within six months of study application; ability to provide informed consent; and ability to attend required follow-up visits. Exclusion criteria include known hypersensitivity to any component of the product; cancer diagnosis or suspicion; active or resected tumour; skeletal immaturity; pregnancy or breastfeeding; active infection at the injection site; open soft-tissue injury; specified metabolic disorders affecting the skeleton; age over 70 years; unstable or malaligned joint greater than 5 degrees; severe osteoarthritis classified as Kellgren-Lawrence grade 4, including bone-on-bone joints with no detectable cartilage; hypersensitivity to citrate or somatropin; inability to provide informed consent; or inability to attend required follow-up visits.
The primary endpoint is the proportion of participants achieving treatment success at six months, defined as a ≥30% improvement from baseline in the joint-specific functional score compared with the control group. FAOS will be used for participants with ankle osteoarthritis and WOMAC for participants with knee osteoarthritis. Secondary assessments include clinical assessment of symptoms and function at three months and six months, as well as repeat MRI and X-ray imaging at six months.
Blood samples will be collected for HGH measurement, including samples taken before and two hours after each injection following the baseline assessment. These measurements will be used to assess systemic exposure and the local versus systemic pharmacodynamic effects of the intervention. Safety will also be monitored through adverse-event assessment, laboratory testing and ongoing independent medical review.
The study hypothesises that intra-articular rhGH combined with PRP, administered within the standardised joint-distraction protocol, will improve clinical outcomes in patients with treatment-resistant knee or ankle osteoarthritis compared with saline placebo. The study is intended to provide preliminary evidence of efficacy and safety and inform the design of a subsequent Phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- There will be 4 arms of the study. One active treatment for ankle injections, one active treatment for knee injections, one saline placebo control group for ankle injections and one saline placebo control group for knee injections.
| Arm | Type | Receives |
|---|---|---|
| Treatment of Ankle Arthritis | Active comparator | Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich PlasmaInjection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. |
| Treatment of Knee Arthritis | Active comparator | Drug: Intra-Articular Injection of Growth Hormone and Platelet-Rich PlasmaInjection of 15 iu of Somatropin and 10ml of Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. |
| Placebo Saline Control Arm for Knee | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. |
| Placebo Saline Control Arm for Ankle | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Injection of sterile saline, volume matched to the active treatment (10ml-12ml) intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be five total injections for the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ankle/Knee arthritis resistant to treatment in GP clinic setting.
- Radiographically confirmed cartilage injury with Kellgren-Lawrence grade 1-3 can be shown on MRI scan or weight bearing X-Ray within 6 months of study application.
- Able to give informed consent to participate in a clinical trial.
- Able to commit to attending a clinic for follow up.
Key exclusion criteria (15 listed)
- Known contraindications for ARTG registered somatropin from various manufacturers (Humatrope, Genotropin) have been used to guide the development of somatropin-related exclusion criteria.
- A known hypersensitivity to any of the components of the product.
- Cancer diagnosis or suspicion.
- Resected or active tumour.
- Skeletally immature (<18 years of age or no radiographic evidence of closure of epiphyses).
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 |
|---|---|---|
| Intra-Articular Injection of Growth Hormone and Platelet-Rich PlasmaIntervention will be an intra-articular injection of 15 units of HGH and 10 mL PRP conjunct. Five total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound. | Drug | Treatment of Ankle Arthritis, Treatment of Knee Arthritis |
| Saline (NaCl 0,9 %) (placebo)To enable a double-blind 1:1 randomised controlled design, the control arm will receive intra-articular sterile saline (0.9% sodium chloride) as placebo. Normal saline is the standard placebo used in many intra-articular injection trials for osteoarthritis. It can be easily matched for volume (~10-12 mL) and appearance (using identical opaque syringes and study codes) to maintain effective blinding for participants, injecting physicians, and outcome assessors. | Drug | Placebo Saline Control Arm for Ankle, Placebo Saline Control Arm for Knee |
Primary outcome
Ankle mobility and functionality test with FAOS scale
Time frame: Baseline, 6-months after final injection
The Foot and Ankle Outcome Score (FAOS) scale is a widely used outcome measure for ankle and hindfoot conditions, including ankle arthritis, assessing pain, function, and alignment, with scores ranging from 0 to 100, where higher scores indicate better function.
Knee mobility and functionality test with WOMAC scale
Time frame: Baseline, 6-months after final injection
The Western Ontario and McMaster Universities Arthritic Index (WOMAC) is a validated self-administered health status measure used in assessing pain, stiffness, and function in patients with arthritic knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation, with the score range being 0-68. A higher score indicates worse symptons.
2 secondary outcomes
MRI Imaging of the affected arthritic joint
Time frame: Baseline, 6-months after final injection
Blood test for hormone
Time frame: Baseline, 2 hours after each injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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.
Reza Salleh, Associate Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma in people with Arthritis Ankle and Arthritis Knee, run by Integrant Pty Ltd at 1 site in Australia.
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 4 inclusion and 15 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: opening soon, as of the sponsor's last update on 26 Aug 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 Australia. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zadane F Bachmid (+61 426 672 977, zadane@integrant.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle mobility and functionality test with FAOS scale (time frame: Baseline, 6-months after final injection). The study lists 2 primary outcomes in all. 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 26 Aug 2026.