Status:
COMPLETED
Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema
Lead Sponsor:
Nij Smellinghe Hosptial
Conditions:
Lymphedema
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Although there is no doubt about the need for compression therapy in lymphoedema, it is not investigated in much detail how much pressure is needed to get optimum volume reduction. New research sugges...
Detailed Description
Lymphoedema is a chronic swelling caused by the regional accumulation of protein-rich fluid in tissues due to a compromised lymphatic system. This may present as primary lymphoedema, defined as congen...
Eligibility Criteria
Inclusion
- Mobile males or females, age 18 years or older
- Subject is mobile and able to walk minimum 5000 steps
- Subject has unilateral or bilateral leg lymphoedema of primary or secondary origin
- Maximum leg circumference at C position is 60 cm or less
- Subject has more or equal than 5 mm pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- Subject requires intense bandaging therapy
- ABPI \>= 0.8
- Willing to give written informed consent and willing to comply with the study protocol
Exclusion
- Known pregnancy
- Evidence of active cancer with potential or known risk of metastasis
- Cancer treatments (surgery, chemotherapy, radiotherapy) not completed at least 6 months prior to randomisation
- Lobes, that a proper bandage application is not possible
- Lobes in the area where a pressure sensor needs to be placed
- A period of intense daily bandaging within the last month
- Any oedema not directly related to lymph failure (e.g. related to heart, renal disease etc.)
- Diuretic treatments
- Paralysis or neuropathy of the legs
- Clinical infection of the legs (e.g. erysipelas)
- Postthrombotic syndrome and/or medical conditions that are contraindicated for compression therapy
- History of allergic reactions to study material
- Participation in any other prospective clinical study that can potentially interfere with this study
- Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01828606
Start Date
April 1 2013
End Date
September 1 2014
Last Update
February 10 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermato-venerologisk afd. og videncenter for sårheling D/S Bispebjerg Hospital
København NV, Denmark, DK 2400
2
Lympho-Opt GmbH
Pommelsbrunn, Germany, 91224
3
Nij Smellinghe hospital
Drachten, Provincie Friesland, Netherlands, 9202NN