Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema

Primary Lower Limb Lymphedema Clinical Trial

Official title:

Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234674
• Other study ID #: 2014-A00355-42
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: May 21, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: Stendo
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

This study is a pilot controlled randomized study with two arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.

• Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)

• Patient aged 18 or more

Exclusion Criteria:

• Patient with a severe heart, kidney or liver failure,

• Patient with an advanced obstructive arterial disease

• Patient with a recent and progressive deep venous thrombosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema
• Primary Lower Limb Lymphedema
• Secondary Lower Limb Lymphedema

Intervention

Other:
• Current intensive CDP
Standard Intensive CDP including manual lymph drainage, pressotherapy and bandaging
• intensive CDP where Stendo pulsating suit replaces pressotherapy
The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.

Locations

Country	Name	City	State
France	CHIC Des Andaines	La FERTE MACE

Sponsors (1)

Lead Sponsor	Collaborator
Stendo

Country where clinical trial is conducted

France, 

References & Publications (2)

Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1) — View Citation

Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. Epub 2007 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume of the most affected leg	Change in % of the volume of the most affected leg according to disk model method	baseline ; after 5 days intensive CDP	Yes
Secondary	Quality of Life	36 health survey questionnaire (SF-36) and Visual Analogical Scale	baseline ; after 5 days intensive CDP	No