LymphoedemaIMPRESSNCT03825263
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
A study testing Intermittent Pressure Compression in people with Lymphoedema, run by University of South Wales 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, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoedema
- What is being tested?
- Intermittent Pressure Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to 28 Feb 2018
- 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 years and older
- 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
- Any of these conditions
- 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: a Feasibility Study
The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.
Read the detailed description
This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.
- Conditions
- Lymphoedema
- Being tested
- Intermittent Pressure Compression
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pressure CompressionDevice
Also called Lymphassist
The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive normal treatment |
| Intervention | Experimental | Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment Receives: Device: Intermittent Pressure Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Limb Volume
Change in limb volume
Measured: 3 and 6 months of treatment
Secondary outcomes (2)
Assessment of IPC use on the Quality of Life: QOL Scores
Change in QOL Scores. Using the Quality of LifeEnjoyment and Satisfication Questionairre short form (Q-LES-Q-SF) with 14 items. Score range is from 14 to 70.
Measured: 3 and 6 months
Use of Perometer
Comparison of limb volume measurement methods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start10 May 2017
- Primary completion17 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphoedemaStudies 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
- Model description
- Observational control trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Cwm Taf University Health Board (NHS)
- Responsible party
- Sponsor
- Investigators
- Mark Williams, Phd, Principal investigator, University of South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825263
- Sponsor's protocol ID
- IMPRESS
- Acronym
- IMPRESS
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunn N, Williams EM, Fishbourne M, Dolan G, Davies JH. Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study. Pilot Feasibility Stud. 2019 Sep 30;5:113. doi: 10.1186/s40814-019-0496-4. eCollection 2019.
PubMed 31583112
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03825263
- Acronym / sponsor ID
- IMPRESS / IMPRESS
- Conditions
- Lymphoedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Collaborators
- Cwm Taf University Health Board (NHS)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 31 Jan 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, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.
Detailed description
This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive normal treatment |
| Intervention | Experimental | Device: Intermittent Pressure CompressionParticipants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment |
Who may qualify
- Ages
- 18 years and older
- 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)
- Any of these conditions
- 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.
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 Pressure CompressionAlso: LymphassistThe intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period. | Device | Intervention |
Primary outcome
Lower Limb Volume
Time frame: 3 and 6 months of treatment
Change in limb volume
2 secondary outcomes
Assessment of IPC use on the Quality of Life: QOL Scores
Time frame: 3 and 6 months
Use of Perometer
Time frame: 6 months
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 31 Jan 2019.
- Derived from this study: PubMed 31583112Dunn N, Williams EM, Fishbourne M, Dolan G, Davies JH. Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study. Pilot Feasibility Stud. 2019 Sep 30;5:113. doi: 10.1186/s40814-019-0496-4. eCollection 2019.
- 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 Pressure Compression in people with Lymphoedema, run by University of South Wales 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 31 Jan 2019. 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?
Lower Limb Volume (time frame: 3 and 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825263, which also lists 1 linked publication.
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 31 Jan 2019.