Lymphoedema of LegIMPRESS IINCT03856281
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
A study testing Intermittent Pneumatic Compression in people with Lymphoedema of Leg, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
Trial summary
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lymphoedema of Leg
- What is being tested?
- Intermittent Pneumatic Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2018to 10 Dec 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over,
- Able to provide written consent,
- Confirmed diagnosis of lower limb ISL stage II or III.
Who cannot join
- • Unable to provide written consent
- Severe congestive heart failure
- Severe skin problems, lower limb ulcers or wounds.
- Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol.
- Non-pitting chronic lymphoedema.
- Known or suspected deep vein thrombosis.
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- Pulmonary embolism.
- Thrombophlebitis.
- Acute inflammation of the skin (erysipelas, cellulitis).
- Uncontrolled/severe cardiac failure.
- Pulmonary oedema.
- Ischaemic vascular disease.
- Active cancer diagnosis.
- Active metastatic diseases affecting the oedematous region.
- Oedema at the root of the extremity or truncal oedema.
- Severe peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.
Read the detailed description
The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.
- Conditions
- Lymphoedema of Leg
- Being tested
- Intermittent Pneumatic Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pneumatic CompressionDevice
Also called LymphAssist
Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group A | Experimental | LymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. Receives: Device: Intermittent Pneumatic Compression |
| Intervention Group B | Experimental | Sequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. Receives: Device: Intermittent Pneumatic Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Volume
Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls
Measured: 5 weeks
Secondary outcomes (2)
Myoton Scores
The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D)
Measured: 5 weeks
Quality of Life Scores
The effect IPC has on quality of life scores - raw score created from a series of Likert Scales
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start10 Jul 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoedema of LegStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- University of South Wales
- Responsible party
- Sponsor
- Investigators
- Mark Williams, PhD, Principal investigator, University of South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856281
- Sponsor's protocol ID
- IMPRESS II
- Acronym
- IMPRESS II
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
- ClinicalTrials.gov ID
- NCT03856281
- Acronym / sponsor ID
- IMPRESS II / IMPRESS II
- Conditions
- Lymphoedema of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- University of South Wales
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- 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.
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.
Detailed description
The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group A | Experimental | Device: Intermittent Pneumatic CompressionLymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. |
| Intervention Group B | Experimental | Device: Intermittent Pneumatic CompressionSequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over,
- Able to provide written consent,
- Confirmed diagnosis of lower limb ISL stage II or III.
Key exclusion criteria (16 listed)
- • Unable to provide written consent
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 |
|---|---|---|
| Intermittent Pneumatic CompressionAlso: LymphAssistParticipants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period | Device | Intervention Group A, Intervention Group B |
Primary outcome
Leg Volume
Time frame: 5 weeks
Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls
2 secondary outcomes
Myoton Scores
Time frame: 5 weeks
Quality of Life Scores
Time frame: 5 weeks
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Mark Williams, PhD principal investigator
University of South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression in people with Lymphoedema of Leg, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
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 3 inclusion and 16 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 27 Jan 2020. 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 United Kingdom. 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. 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?
Leg Volume (time frame: 5 weeks). 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 27 Jan 2020.