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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Acute unilateral Achilles tendon rupture or isolated Ankle Fracture

• Treatment starts within 10 days in a hospital setting

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Luigi Belcastro, RN
luigi.belcastro@sll.se
+46724641144
Backup
Simon Svedman, MD
Simon.svedman@ki.se
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1400
Treatments
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.
Sponsors
Collaborators: Norra Älvsborgs Länssjukhus, Alingsås Lasarett, Uppsala University Hospital, Uddevalla Hospital, Danderyd Hospital, Norrtälje Hospital, Gävle Hospital, Lugano Regional Hospital, Stockholm South General Hospital, Helsingborgs Hospital, Istituto Ortopedico Rizzoli, University Hospital, Akershus, Östersund Hospital, Sahlgrenska University Hospital, Höglandssjukhuset Eksjö
Leads: Karolinska University Hospital

This content was sourced from clinicaltrials.gov