EdemaNCT01389089
Effective Treatment of Posttraumatic and Postoperative Edema
A study testing ice gel pack, Multi-layer compression bandage and A-V Impulse compression in people with Edema, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edema
- What is being tested?
- ice gel pack, Multi-layer compression bandage and A-V Impulse compression
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Jan 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Inpatients
- Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
- No walking aids before trauma
- Written informed consent
- Monotrauma
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- Preoperative and/or postoperative edema
- Preoperative inclusion
- if delay of surgery due to ankle edema
- if fracture stable enough for temporary removal of orthesis
Who cannot join
- Diabetes Mellitus
- Lymphedema
- Peripheral arterial occlusive disease (PAD)
- Decompensated heart failure or renal insufficiency
- Acute bacterial infection
- Severe osteoporosis
Show all 17Show fewer
- Pathological fractures
- Known tumors
- Postthrombotic syndrome
- Thrombosis
- Open fractures
- Polytrauma, cerebral trauma
- Neurological deficiencies
- Diuretics
- Pregnancy
- Alcohol or drug abuse
- Psychological disorders
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Luzerner Kantonsspital, Unfallchirurgie
Lucerne, 6000 16
About this study
Official title: Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice
Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.
Read the detailed description
After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.
- Conditions
- Edema
- Being tested
- ice gel pack, Multi-layer compression bandage, A-V Impulse compression
- Keywords
- edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice gel packBehavioural
ice gel pack combined with elevation
Multi-layer compression bandageOther
Also called Artiflex, Comprilan
Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).
A-V Impulse compressionDevice
Also called A-V intermittent Impulse compression device., AVI
A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | The Control group received ice gel packs and elevation to reduce edema. Receives: Behavioral: ice gel pack |
| Multi-layer compression bandage | Experimental | A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated. Receives: Other: Multi-layer compression bandage |
| A-V Impulse compression | Active comparator | An A-V Impulse compression device was used to reduce edema. Receives: Device: A-V Impulse compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle edema as measured with the figure-of-eight20 method
The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Secondary outcomes (12)
Pain scores measured on the Visual Analogue Scale (VAS)
Visual Analogue Scales were used to assess a daily pain score reflecting strongest and average pain perceived during the previous 24 hours, night pain and pain frequency.
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.
Patient satisfaction with treatment scores measured on the Visual Analogue Scale
Visual Analogue Scales were used to assess patient satisfaction with the assigned treatment. The patients had to record their satisfaction with the treatment before surgery and after surgery.
Measured: Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.
Number of days until possible operation
The surgeon daily had to assess whether the patient was ready for operation or not. The wrinkling test served as a criteria for decision making. Accordingly the number of days until possible operation was recorded.
Measured: Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.
Number of postoperative hospitalization days
Postoperatively the physiotherapist each day had to record whether or not the patient was ready for discharge. Discharge criteria: 1. patient is able to walk 20 meters and one flight of stairs with crutches. 2. the wound is dry and not irritated. Accordingly, the number of days of postoperative hospitalization until discharge criteria were reached was recorded.
Measured: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.
Range of motion of the ankle joint and foot.
Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.
Measured: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.
Amount of daily intake of medication
The intake of daily pain medication was recorded for the instay period (Dafalgan, Novalgin, opiates). Furthermore, the patient file was screened for any Nonsteroidal anti-inflammatory drugs (not allowed).
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Number of adverse events as a measure of safety in each group
Adverse events were defined as:
bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.
Lower limb function (Foot and ankle ability measure)
Questionnaire, self-assessed by the patient. To assess function and participation.
Measured: 12 weeks postoperative, 1 year postoperative.
General Health (SF-36)
Generic assessment of the health status with the SF-36.
Measured: 12 weeks postoperative,1 year postoperative.
Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale
Patients had to record on the VAS on how satisfied they were with the overall outcome.
Measured: 12 weeks and 1 year postoperative.
Amount of volumetric lower limb edema
Measurements of circumference of the lower limb were used to calculate lower limb volume. The circumferences of the lower limb were measured in increments of 4 cm from ankle level until below the knee joint.
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Number of complains of discomfort or intolerances considering the intervention
Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).
Measured: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Orthofix Inc., Medtronic - MITG
- Responsible party
- Principal investigator, Reto Babst, Luzerner Kantonsspital
- Investigators
- Reto Babst, Prof.Dr.med., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389089
- Sponsor's protocol ID
- 616
- Status last verified
- Oct 2023
- First submitted
- 23 Jun 2011
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice
- ClinicalTrials.gov ID
- NCT01389089
- Acronym / sponsor ID
- 616
- Conditions
- Edema
- Keywords
- edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Orthofix Inc., Medtronic - MITG
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.
Detailed description
After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Behavioral: ice gel packThe Control group received ice gel packs and elevation to reduce edema. |
| Multi-layer compression bandage | Experimental | Other: Multi-layer compression bandageA multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated. |
| A-V Impulse compression | Active comparator | Device: A-V Impulse compressionAn A-V Impulse compression device was used to reduce edema. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years
- Inpatients
- Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
- No walking aids before trauma
- Written informed consent
Key exclusion criteria (17 listed)
- Diabetes Mellitus
- Lymphedema
- Peripheral arterial occlusive disease (PAD)
- Decompensated heart failure or renal insufficiency
- Acute bacterial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ice gel packice gel pack combined with elevation | Behavioural | Control group |
| Multi-layer compression bandageAlso: Artiflex, ComprilanApplication of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage). | Other | Multi-layer compression bandage |
| A-V Impulse compressionAlso: A-V intermittent Impulse compression device., AVIA-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second. | Device | A-V Impulse compression |
Primary outcome
Ankle edema as measured with the figure-of-eight20 method
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.
12 secondary outcomes
Pain scores measured on the Visual Analogue Scale (VAS)
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.
Patient satisfaction with treatment scores measured on the Visual Analogue Scale
Time frame: Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.
Number of days until possible operation
Time frame: Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.
Number of postoperative hospitalization days
Time frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.
Range of motion of the ankle joint and foot.
Time frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.
Amount of daily intake of medication
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Number of adverse events as a measure of safety in each group
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.
Lower limb function (Foot and ankle ability measure)
Time frame: 12 weeks postoperative, 1 year postoperative.
General Health (SF-36)
Time frame: 12 weeks postoperative,1 year postoperative.
Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale
Time frame: 12 weeks and 1 year postoperative.
Amount of volumetric lower limb edema
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Number of complains of discomfort or intolerances considering the intervention
Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Babst, Prof.Dr.med. principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ice gel pack, Multi-layer compression bandage and A-V Impulse compression in people with Edema, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 5 Oct 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle edema as measured with the figure-of-eight20 method (time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2023.