Clinical trial NCT04461132: The Effect of Manual Lymphatic Drainage
Official title: Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Venous Insufficiency
Lymphatic Disease
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
Collaborators: name: Istanbul Health Sciences University
First posted: 2020-07-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.


Eligibility criteria: Inclusion Criteria:

* with venous ulcer unhealing for at least 6 weeks
* Without enfection
* vascular surgery is not indicated
* There is no obstruction to apply MLD and compression to lower extremty

Exclusion Criteria:

* with diabetic mellutus
* with enfection
* with ABI\<0,7
* Patients who have undergone venous vascular surgery
* Patients undergoing active wound closure treatment

Primary outcomes:
measure: Evaluation of wound healing
timeFrame: Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.
measure: Evaluation of range of motion of ankle
timeFrame: Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.
measure: Evaluation of pain
timeFrame: Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.
measure: evaluation of edema
timeFrame: Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.
measure: evaluation of quality of life
timeFrame: Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Saglık Bilimleri University
Study officials:
affiliation: University of Health science
name: Nilüfer Kablan, PhD
role: STUDY_DIRECTOR
References:
citation: Azoubel R, Torres Gde V, da Silva LW, Gomes FV, dos Reis LA. [Effects of the decongestive physiotherapy in the healing of venous ulcers]. Rev Esc Enferm USP. 2010 Dec;44(4):1085-92. doi: 10.1590/s0080-62342010000400033. Portuguese.
citation: Crawford JM, Lal BK, Duran WN, Pappas PJ. Pathophysiology of venous ulceration. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):596-605. doi: 10.1016/j.jvsv.2017.03.015.
citation: de Roos KP, Wittens CH, Maessen-Visch MB, van der Wegen-Franken CP. [Universal Dutch guideline on 'Venous disease']. Ned Tijdschr Geneeskd. 2014;158(0):A8076. Dutch.
citation: Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. doi: 10.12968/bjcn.2010.15.Sup3.47365.
citation: Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.
citation: Hampton S. An introduction to various types of leg ulcers and their management. Br J Nurs. 2006 Jun 8-21;15(11):S9-13. doi: 10.12968/bjon.2006.15.Sup2.21235.