Outpatient prevention of leg clots in patients with ankle fractures or Achilles tendon ruptures
Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
This study tests if a special air compression treatment can help prevent blood clots and improve healing in patients with ankle fractures or Achilles tendon ruptures who are in a cast.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT03259204 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intermittent pneumatic compression (IPC) therapy in preventing venous thromboembolism (VTE) and improving healing in patients with ankle fractures or Achilles tendon ruptures who are immobilized. The study will enroll 1,400 patients and compare the outcomes of those receiving IPC therapy to those receiving standard plaster cast treatment. Participants will undergo clinical examinations and Doppler ultrasound screening for VTE, ensuring safety and timely intervention if necessary. The goal is to establish a new standard of care for outpatient management of these injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals with acute unilateral Achilles tendon ruptures or isolated ankle fractures who can start treatment within 10 days in a hospital setting.
Not a fit: Patients with known kidney disorders, heart failure with pitting edema, malignancies, bleeding disorders, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of VTE and improve healing outcomes for patients with leg immobilization.
How similar studies have performed: While IPC is commonly used in hospitalized patients, its application in outpatient settings for this specific purpose is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute unilateral Achilles tendon rupture or isolated Ankle Fracture * Treatment starts within 10 days in a hospital setting Exclusion Criteria: * Inability or refusal to give informed consent for participation in the study * Inability to comply with the study instructions * Known kidney disorder * Heart failure with pitting oedema * Presence of known malignancy * Current bleeding disorder * Pregnancy * Planned follow-up at another hospital * Pilon fracture
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Paul W Ackermann, MD, PhD — Karolinska University Hospital, 171 76 Stockholm, SWEDEN
- Study coordinator: Luigi Belcastro, RN
- Email: luigi.belcastro@sll.se
- Phone: +46724641144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.