ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000162213

Ethics application status

Approved

Date submitted

11/01/2018

Date registered

2/02/2018

Date last updated

30/06/2021

Date data sharing statement initially provided

30/06/2021

Date results provided

30/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Measuring skin and tissue change before and after compression: a comparative study of people with and without primary lymphoedema

Scientific title

Dermal composition and related measures: response to pneumatic compression in people with and without primary lymphoedema.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1206-9482

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Primary lymphoedema

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Physical Medicine / Rehabilitation

Physiotherapy

Skin

Normal skin development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Intermittent pneumatic compression (IPC) will be applied to people with no lymphoedema, age and gender matched to a lymphoedema participant for comparison of their response to IPC.

Control group

Active

Outcomes

Primary outcome [1]

Dermal depth as assessed with high frequency ultrasound using the DermaScan C of frequency 20MHz. Two points will be measured on both the affected (treated) and contra-lateral untreated limb. These two points-the foot and the calf- on both limbs will be used for assessment for each outcome.

Timepoint [1]

Before and after one application of intermittent pneumatic compression (IPC).

Primary outcome [2]

Fluid component of the skin assessed using a DermaScan C high frequency ultrasound (frequency of 20MHz). A scale from 0 - 255 represents the full range of intensity of echoes seen in B-scan mode: the component of the image that relates to fluid (low intensity) will be represented by the range of 0-30.

Timepoint [2]

Before and after one application of IPC.

Secondary outcome [1]

Skin resistance assessed using the Indurometer BME 1563G, a tonometer developed by Flinders University.

Timepoint [1]

Before and after one application of IPC.

Secondary outcome [2]

Bioimpedance spectroscopy assessed using an Impedimed device (SFB7).

Timepoint [2]

Before and after one application of IPC.

Secondary outcome [3]

Limb circumference of the affected and unaffected limb (treated and non-treated limb). Circumferences will be taken at a point where the high frequency ultrasound (HFU) is to be applied and at a clinically relevant point for each limb.

Timepoint [3]

Before and after one application of IPC.

Secondary outcome [4]

A measure of skin moisture (tissue dialectric constant), as measured by the MoistureMeterD manufactured by Delfin Technologies. This will be measured at three points on both the limb to be treated and the limb not treated.

Timepoint [4]

Before and after one application of IPC

Eligibility

Key inclusion criteria

People with primary lymphoedema and people without primary lymphoedema age and gender matched to those with primary lymphoedema.

Minimum age

3 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Other

Other design features

The same intervention is applied to both groups in this study. The difference between groups is inherent to the group (lymphoedema or no lymphoedema). So all receive the same intervention and the difference in response will be investigated.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size will be re-evaluated after measurement of 10 people in the pilot. Numbers of people with primary lymphoedema are low: while sample size estimate is 100 participants, with 50 per group involving recruitment over three states, the sample size will be determined by numbers of people with primary lymphoedema within the age and inclusion criteria available to participate.
Statistical Methods:
1. Comparative data, including mean, median, standard deviation and range will be described for all measures of dermal and soft tissue properties and, for within group analysis will be sub-grouped for age and gender, as Non lymphoedema (NLO) and primary lympheodema (PLO) are matched across groups. As numbers at each age may be small, the effect of age will also be investigated by groups of ages: e.g. children from 3-4 years and from 5-9 years, adolescents from 10-18 years and adults 19-40 years. HFU images will be investigated for intra-rater reliability.
2. Comparative measures will be investigated for significant difference within those with lymphoedema (within group PLO), stratified by age and duration of lymphoedema.
3. Comparative measures will be investigated for significant difference between study groups matched by age, gender and limb dominance and stratified for ethnicity. Matching of the PLO group with a NLO control group by age, gender and limb dominance will offset the relatively low numbers in each age and control for effect of limb dominance in volume measures.
4. The convergence validity of clinical assessment tools:
• Circumference measures (at point of interest).
• Bioimpedance,
• MoistureMeter,
• Indurometer
will be investigated, in measures of agreement with dermal changes as identified with HFU, utilising SPSS.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/02/2018

Actual

22/11/2018

Date of last participant enrolment

Anticipated

31/01/2019

Actual

12/12/2019

Date of last data collection

Anticipated

8/02/2019

Actual

12/12/2019

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment hospital [2]

Mercy Hospital for Women - Heidelberg

Recruitment hospital [3]

Mt Wilga Private Hospital - Hornsby

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

2077 - Hornsby

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Rd,
Bedford Park
South Australia SA 5042

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Sturt Rd
Bedford Park
SA 5042

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Murdoch Children's Research Institute

Address [1]

Murdoch Children's Research Institute
50 Flemington Road
Parkville
VIC 3052

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Rotary Health

Address [2]

2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Postal Address
PO Box 3455,
Parramatta NSW 2124

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Childrens Hospital Melbourne HREC

Ethics committee address [1]

The Royal Childrens Hospital Melbourne
50 Flemington Road Parkville Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/09/2016

Approval date [1]

19/12/2016

Ethics approval number [1]

HREC/16/RCHM/136

Ethics committee name [2]

Mercy Health Human Research Ethics Committee

Ethics committee address [2]

Mercy Hospital for Women 
163 Studley Road 
Heidelberg, VIC 3084

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/10/2016

Approval date [2]

21/02/2017

Ethics approval number [2]

R16/67

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374214-36273A_Approval__Ethics Multisite_Primary LO (19.12.2016).pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/374214-36273B Approval_Ethics (Multisite) (17.10.2017).pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/374214-36273C Approval Ethics (Multisite) (08.11.2017).pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/374214-Master_Adult PICF_lymphoedema_v3_10102017.pdf (Participant information/consent)

Attachments [5]

/AnzctrAttachments/374214-Master_Adult Non_LO_PICF_v3_10102017.pdf (Participant information/consent)

Attachments [6]

/AnzctrAttachments/374214-Master_PICF ParentGuardian lymphoedema v2 03102017.pdf (Participant information/consent)

Attachments [7]

/AnzctrAttachments/374214-Master_ParentGuardian_NonLO_PICF v2 03102017.pdf (Participant information/consent)

Contacts

Principal investigator

Name

Ms Jane Phillips

Address

Murdoch Childrens Research Institute
50 Flemington Rd
Parkville Vic 3052

Country

Australia

Phone

+61 418 104 690

Fax

jane.phillips@flinders.edu.au

Contact person for public queries

Name

Jane Phillips

Address

Murdoch Childrens Research Institute
50 Flemington Rd
Parkville Vic 3052

Country

Australia

Phone

+61 418 104 690

Fax

jane.phillips@flinders.edu.au

Contact person for scientific queries

Name

Jane Phillips

Address

Murdoch Childrens Research Institute
50 Flemington Rd
Parkville Vic 3052

Country

Australia

Phone

+61 418 104 690

Fax

jane.phillips@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12371	Ethical approval					374214-(Uploaded-06-01-2020-12-05-16)-Study-related document.pdf

Results publications and other study-related documents

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No additional documents have been identified.

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