NCT03259204

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

6.3 years

First QC Date

August 16, 2017

Last Update Submit

March 5, 2024

Conditions

Achilles Tendon RuptureAnkle FracturesVenous Thromboembolism

Keywords

Achilles tendonMicrodialysisImmobilizationWound healingIntermittent Pneumatic CompressionUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Venous Thromboembolic Events (VTE)

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

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

Secondary Outcomes (10)

  • Patient reported Outcome - ATRS

    6 months and 1 year

  • Patient reported Outcome - FAOS

    6 months and 1 year

  • Patient reported Outcome - OMAS

    6 months and 1 year

  • Patient reported Outcome - EQ-5D-5L

    6 months and 1 year

  • Functional outcome - muscular endurance tests (heel-rise)

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Leg Immobilization

NO INTERVENTION

Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.

Adjuvant IPC

EXPERIMENTAL

Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.

Device: Adjuvant IPC

Interventions

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.

Adjuvant IPC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27909125BACKGROUND

  • 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.

    PMID: 27535264BACKGROUND

  • 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.

    PMID: 25922463BACKGROUND

  • 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.

    PMID: 28668970BACKGROUND

  • 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.

    PMID: 34016662DERIVED

Related Links

MeSH Terms

Conditions

Ankle FracturesVenous Thromboembolism

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Paul W Ackermann, MD, PhD

    Karolinska University Hospital, 171 76 Stockholm, SWEDEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Belcastro, RN

CONTACT

+46724641144luigi.belcastro@sll.se

Simon Svedman, MD

CONTACT

Simon.svedman@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 23, 2017

Study Start

September 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Data will be shared on reasonable requests.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After completion of the study.
Access Criteria
Data will be shared on reasonable requests to the steering committee.

Locations

SE(1)