NCT07650396 The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions
| NCT ID | NCT07650396 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Erasmus Medical Center |
| Condition | Achilles Tendinopathy (AT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 276 participants in total. It began in 2026-06-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Achilles tendinopathy is a common and often persistent tendon disorder associated with pain, impaired function, and reduced participation in physical activities. Standard care consists of education, load management advice, and progressive calf-strengthening exercises, yet about half of patients remain symptomatic. Corticosteroid injections are frequently used in clinical practice, but evidence on long-term efficacy and safety remains inconclusive. The ASPIRE trial is a multicentre, randomized, double-blind, placebo-controlled phase III trial evaluating whether 1-3 ultrasound-guided peritendinous corticosteroid injections added to standard care are safe and more effective than placebo injections plus standard care in adults with chronic midportion Achilles tendinopathy. The primary outcomes are change in VISA-A score over 1 year and incidence of full-thickness Achilles tendon rupture during 1-year follow-up.
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years * Clinically diagnosed midportion Achilles tendinopathy confirmed by ultrasound * Symptoms for at least 6 months * Persistent complaints despite standard care, including education, load management advice and at least 3 months of exercise therapy / exercise programme Exclusion Criteria: * • Clinical suspicion of insertional Achilles tendinopathy * Clinical suspicion of Achilles tendon rupture * Clinical suspicion of plantar flexor tenosynovitis * Clinical suspicion of sural nerve pathology * Clinical suspicion of peroneal tendon subluxation or peroneal tendinopathy * Clinical suspicion of posterior ankle impingement syndrome * Suspected systemic/inflammatory disorder as cause of symptoms * Any condition preventing participation in active exercise programme * History of Achilles tendon rupture of index tendon * Previous local corticosteroid injection on index Achilles tendon * Previous surgery on index Achilles tendon * Refusal to undergo one of the study treatments * Local skin infection, suspected systemic infection with fever, or other medical condition compromising injection safety * Vitamin K antagonist use with INR \>3.0 within 3 days before injection or unknown INR * Current pregnancy or breastfeeding * Medication-induced tendon pathology (quinolones or statins related to symptom onset) * Inability to provide informed consent * Participation in another concomitant interventional programme for Achilles tendinopathy * Known hypersensitivity or allergy to Depo-Medrol or Lidocaine * Participants with unstable or poorly controlled diabetes mellitus may be excluded at investigator discretion for safety reasons.
Contact & Investigator
Robert Jan de Vos, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Centre
Frequently Asked Questions
Who can join the NCT07650396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Achilles Tendinopathy (AT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07650396 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 276 participants.
Is NCT07650396 currently recruiting?
Yes, NCT07650396 is actively recruiting participants. Contact the research team at aspire@erasmusmc.nl for enrollment information.
Where is the NCT07650396 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07650396 clinical trial?
NCT07650396 is sponsored by Erasmus Medical Center. The principal investigator is Robert Jan de Vos, MD, PhD at Erasmus Medical Centre. The trial plans to enroll 276 participants.