Clinical trial NCT03856281: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
Official title: Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema (IMPRESS II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoedema of Leg
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: University of South Wales
First posted: 2019-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over,
* Able to provide written consent,
* Confirmed diagnosis of lower limb ISL stage II or III.

Exclusion Criteria:

* • 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.
  * 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.

Primary outcomes:
measure: Leg Volume
timeFrame: 5 weeks
Secondary outcomes:
measure: Myoton Scores
timeFrame: 5 weeks
measure: Quality of Life Scores
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: Dewi Sant Hospital
Study officials:
affiliation: University of South Wales
name: Mark Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: