NCT02444468

Brief Summary

This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling. The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

April 28, 2015

Last Update Submit

August 17, 2016

Conditions

Ankle FracturesIntermittent Pneumatic CompressionComparative StudyPreoperative Care

Outcome Measures

Primary Outcomes (1)

  • Time from diagnosis-to-surgery

    5 days

Study Arms (2)

IPC and bandage

EXPERIMENTAL

Pneumatic device and bandage

Device: Flowtron ACS800Other: Bandage

Bandage only

ACTIVE COMPARATOR

Bandage only

Other: Bandage

Interventions

Flowtron ACS800DEVICE

Flowtron ACS800 and bandage

IPC and bandage
BandageOTHER

Bandage only

Bandage onlyIPC and bandage

Eligibility Criteria

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

You may qualify if:

  • Malleolar fracture requiring surgery.

You may not qualify if:

  • Severe arteriosclerosis.
  • Known or suspected acute DVT or flebit.
  • Severe decompensated heart failure.
  • Pulmonary embolism.
  • Acute skin conditions as dermatitis, infected wounds or recent skintransplant.
  • Open fracture.
  • Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesper O. Schønnemann

Aabenraa, 6200, Denmark

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Bandages

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Jesper O Schønnemann, Dr

    Hospital southern Jutland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper O Schønnemann, Dr

CONTACT

+4579976170jesper.ougaard.schoennemann1@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 14, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2018

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

DK(1)