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Swedish Multicenter Trial of Outpatient Prevention of Leg Clots (StopLegClots)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259204
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Danderyd Hospital
Stockholm South General Hospital
Uppsala University Hospital
University Hospital, Linkoeping
Visby lasarett
Region Örebro County
Gävle Hospital
Höglandssjukhuset Eksjö
Norrtälje Hospital
Östersunds Hospital
Helsingborgs Hospital
Karlstad Central Hospital
Skövde Hospital
Uddevalla Hospital
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Ankle Fractures Venous Thromboembolism Device: Adjuvant IPC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
No Intervention: Leg Immobilization
Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Experimental: Adjuvant IPC
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
Device: Adjuvant IPC
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.




Primary Outcome Measures :
  1. Venous Thromboembolic Events (VTE) [ Time Frame: Up til the time of removal of leg immobilization, approx. 6-8 weeks ]
    The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism


Secondary Outcome Measures :
  1. Patient reported Outcome - ATRS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)

  2. Patient reported Outcome - FAOS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)

  3. Patient reported Outcome - OMAS [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)

  4. Patient reported Outcome - EQ-5D-5L [ Time Frame: 6 months and 1 year ]
    symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).

  5. Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: 1 year ]
    Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.

  6. Callus production [ Time Frame: 6 weeks ]
    Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.

  7. VTE-preventive mechanisms [ Time Frame: 6 weeks ]
    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 .

  8. Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC [ Time Frame: 6-8 weeks ]
    Efficiancy 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259204


Contacts
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Contact: Luigi Belcastro, RN +46851775678 luigi.belcastro@sll.se
Contact: Simon Svedman, MD Simon.svedman@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Simon Svedman, MD    +46765930550    Simon.svedman@ki.se   
Contact: Luigi Belcastro, RN    +46736994845    luigi.belcastro@sll.se   
Sponsors and Collaborators
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Danderyd Hospital
Stockholm South General Hospital
Uppsala University Hospital
University Hospital, Linkoeping
Visby lasarett
Region Örebro County
Gävle Hospital
Höglandssjukhuset Eksjö
Norrtälje Hospital
Östersunds Hospital
Helsingborgs Hospital
Karlstad Central Hospital
Skövde Hospital
Uddevalla Hospital
Investigators
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Principal Investigator: Paul W Ackermann, MD, PhD Karolinska University Hospital, 171 76 Stockholm, SWEDEN
Additional Information:
Publications:
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Responsible Party: Paul Ackermann, Senior lecturer, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03259204    
Other Study ID Numbers: 2017-00202
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Ackermann, Karolinska University Hospital:
Achilles tendon
Microdialysis
Immobilization
Wound healing
Intermittent Pneumatic Compression
Ultrasonography
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Rupture
Ankle Fractures
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Fractures, Bone