None listed
Conditions
Brief summary
Primary lymphoedema occurs in people with a genetic predisposition and manifests as long-term swelling of a body part. Current assessments provide little understanding of the composition of the underlying tissues and how they respond to treatments. No information has been available about the difference between those with and without lymphoedema with respect to age and skin properties. This study will use high frequency ultrasound (HFU) to investigate differences in skin composition and thickness in people with and without primary lymphoedema. The measures to be used include clinical tools which measure dermal properties (skin resistance and elasticity, and measures of water content and limb volume). The response of the skin to compression, a standard lymphoedema intervention, will then be assessed with HFU and clinical assessment tools, following the application of intermittent pneumatic compression. Children and adults with and without primary lymphoedema, aged between three and 40 years old, will be included. Analysis of clinical tools for a measure of equivalence with HFU findings will inform the use of clinical tools and enable translation of study findings to the clinical setting. Compression is used in healthy populations to support limbs during travel and sport: inclusion in this study of both the healthy population and the understudied childhood lymphoedema population will add to the understanding of the effect of compression on the skin for all groups and form the basis for targeted treatment guidelines. Most lymphoedema research has investigated secondary lymphoedema, despite there being strong growing evidence of underlying genetic predisposition or covert primary lymphoedema in those who develop secondary lymphoedema. The findings of this study will provide a basis for understanding the progression of primary lymphoedema and inform future primary and secondary lymphoedema research.
Interventions
Intermittent pneumatic compression (IPC) will be applied to either an upper or lower limb with lymphoedema in one session only. (Limb treated will be that with most severe lymphoedema; in case of control, the site corresponding to the matched lymphoedema participant.) Device used is a MediRent LX9 with sequential pneumatic pressure applied only to the limb (to axilla in the upper limb (UL) or top of thigh in the lower limb (LL)). Number of cells per sleeve and timing of pressure cycle will be ac
Intermittent pneumatic compression (IPC) will be applied to either an upper or lower limb with lymphoedema in one session only. (Limb treated will be that with most severe lymphoedema; in case of control, the site corresponding to the matched lymphoedema participant.) Device used is a MediRent LX9 with sequential pneumatic pressure applied only to the limb (to axilla in the upper limb (UL) or top of thigh in the lower limb (LL)). Number of cells per sleeve and timing of pressure cycle will be according to the LX9. The dose will be 40mmHg for UL and 60mmHg for LL over 50 minutes; children under 9 years will have 30 mmHg (UL) and 40 mmHg for (LL) over 30 minutes. IPC will be administered by the principal investigator, a physiotherapist. Adherence will not be assessed; study period is one treatment/ attendance.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator)
Eligibility
Sex/Gender
All
Age
3 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
People with primary lymphoedema and people without primary lymphoedema age and gender matched to those with primary lymphoedema.
Exclusion criteria
Exclusion from study if have any of the below: • Have had any skin infection (cellulitis) within previous two months • Have a diagnosed connective tissue disorder e.g. lipodermatosclerosis or local occurrence of a skin condition such as psoriasis; • Have a congenital condition which affects the skin such as Ehlers-Danlos Syndrome or Marfan's Disease Exclusions for Intermittent Pneumatic Compression- will be excluded from the study: • a. Active metastatic disease • b. Known or suspected deep venous thrombosis • c. Pulmonary embolism • d. Thrombophlebitis • e. Uncontrolled cardiac failure • f. Current cellulitis • g. Pulmonary oedema • h. Ischaemic vascular disease • i. Severe peripheral neuropathy • j. Chronic regional pain syndrome Exclusions for bioimpedance spectroscopy only (will participate in all other parts of the study except for bioimpedance): • a. Are pregnant • b. Have a pacemaker or other implanted electronic device • c. Have a metal implant such as pins or plates in bones
Outcome results
None listed