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Achilles Tendon RuptureStopLegClotsNCT03259204

Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

A study testing Adjuvant IPC in people with Achilles Tendon Rupture and Ankle Fractures, run by Karolinska University Hospital at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adjuvant IPC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
1 siteSweden
Study dates
1 Sep 2018to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute unilateral Achilles tendon rupture or isolated Ankle Fracture
  • Treatment starts within 10 days in a hospital setting

Who cannot join

  • 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
Show all 9Show fewer
  • Pregnancy
  • Planned follow-up at another hospital
  • Pilon fracture

Trial locations and contacts

1 site in 1 country.

Luigi Belcastro, RN contact

+46724641144

luigi.belcastro@sll.se

Simon Svedman, MD contact

Simon.svedman@ki.se

Sweden1 site, 1 recruiting

  • Karolinska University Hospital

    Stockholm

    Simon Svedman, MD, Simon.svedman@ki.se

    Luigi Belcastro, RN, +46724641144, luigi.belcastro@sll.se

    Recruiting

Other trials in Sweden

About this study

Official title: Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy

Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments.

This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.

Read the detailed description

The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines.

Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.

Being tested
Adjuvant IPC
Keywords
Achilles tendon, Microdialysis, Immobilization, Wound healing, Intermittent Pneumatic Compression, Ultrasonography
Medical subject headings
Ankle Fractures, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant IPCDevice

    This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.

Study groups in NCT03259204
Study groupRoleWhat they receive
Leg ImmobilizationNo interventionRoutine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Adjuvant IPCExperimentalLeg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
Receives: Device: Adjuvant IPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Venous Thromboembolic Events (VTE)

    The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism

    Measured: Up til the time of removal of leg immobilization, approx. 6-8 weeks

Secondary outcomes (10)

  1. Patient reported Outcome - ATRS

    symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)

    Measured: 6 months and 1 year

  2. Patient reported Outcome - FAOS

    symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)

    Measured: 6 months and 1 year

  3. Patient reported Outcome - OMAS

    symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)

    Measured: 6 months and 1 year

  4. Patient reported Outcome - EQ-5D-5L

    symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).

    Measured: 6 months and 1 year

  5. Functional outcome - muscular endurance tests (heel-rise)

    Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.

    Measured: 1 year

  6. Callus production

    Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.

    Measured: 6 weeks

  7. VTE-preventive mechanisms

    VTE-preventive mechanisms will be analyzed at the 6 week visit by assessments of profibrinolysis and coagulation factors as well as by blood-flow quantification .

    Measured: 6 weeks

  8. Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC

    Efficacy of LMWH with and without the use of IPC as to prevent VTE will be studied in order to confirm the efficency of a commonly used drug for VTE prophylaxis.

    Measured: 6-8 weeks

  9. Patient mortality

    Mortality of patients included will be recorded and investigated for cause of death. If the cause of death is VTE, this will be reported. The overall mortality rate in this study is expected to be low. Mortality will be investigated via patient journals at one year after study inclusion, and at 2 years via national mortality register.

    Measured: 1year and 2 years

  10. Health economic analyses

    Together with Karolinska Institutet, LIME, the trial treatment effects will involve a within-trial evaluation of cost effectiveness integrated into a decision-analytic model of longer run costs and health effects

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start1 Sep 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259204
Sponsor's protocol ID
2017-00202
Other IDs
2017
Acronym
StopLegClots
Status last verified
Mar 2024
First submitted
16 Aug 2017
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared on reasonable requests.

Publications

  • Arverud ED, Anundsson P, Hardell E, Barreng G, Edman G, Latifi A, Labruto F, Ackermann PW. Ageing, deep vein thrombosis and male gender predict poor outcome after acute Achilles tendon rupture. Bone Joint J. 2016 Dec;98-B(12):1635-1641. doi: 10.1302/0301-620X.98B12.BJJ-2016-0008.R1.

    PubMed 27909125

  • Domeij-Arverud E, Ackermann PW. Deep Venous Thrombosis and Tendon Healing. Adv Exp Med Biol. 2016;920:221-8. doi: 10.1007/978-3-319-33943-6_21.

    PubMed 27535264

  • Domeij-Arverud E, Labruto F, Latifi A, Nilsson G, Edman G, Ackermann PW. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilisation: a prospective randomised trial of acute ruptures of the Achilles tendon. Bone Joint J. 2015 May;97-B(5):675-80. doi: 10.1302/0301-620X.97B5.34581.

    PubMed 25922463

  • Abdul Alim M, Domeij-Arverud E, Nilsson G, Edman G, Ackermann PW. Achilles tendon rupture healing is enhanced by intermittent pneumatic compression upregulating collagen type I synthesis. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2021-2029. doi: 10.1007/s00167-017-4621-8. Epub 2017 Jul 1.

    PubMed 28668970

  • Svedman S, Alkner B, Berg HE, Domeij-Arverud E, Jonsson K, Nilsson Helander K, Ackermann PW. STOP leg clots-Swedish multicentre trial of outpatient prevention of leg clots: study protocol for a randomised controlled trial on the efficacy of intermittent pneumatic compression on venous thromboembolism in lower leg immobilised patients. BMJ Open. 2021 May 20;11(5):e044103. doi: 10.1136/bmjopen-2020-044103.

    PubMed 34016662

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant IPC in people with Achilles Tendon Rupture and Ankle Fractures, run by Karolinska University Hospital at 1 site in Sweden.

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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luigi Belcastro, RN (+46724641144, luigi.belcastro@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous Thromboembolic Events (VTE) (time frame: Up til the time of removal of leg immobilization, approx. 6-8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259204, which also lists 5 linked publications.

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 7 Mar 2024.

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